Gastrointestinal Stromal Tumors
Conditions
Keywords
Gastrointestinal stromal tumors, DS-6157a, Anti-drug antibody conjugate, G-protein coupled receptor 20 (GPR20)
Brief summary
This study will assess the safety, efficacy, and pharmacokinetics of DS-6157a in participants with advanced gastrointestinal stromal tumors (GIST).
Detailed description
This study is a two-part, multicenter, open-label, multiple-dose, first-in-human study of the antibody-drug conjugate (ADC) DS-6157a given as a single agent to participants with gastrointestinal stromal tumor (GIST). This study will include 2 parts: 1. Dose Escalation (Part 1) 2. Dose Expansion (Part 2) Dose Escalation: Participants with histopathologically documented advanced GIST not amenable to curative therapy may be included in which the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of DS-6157a monotherapy will be determined. Dose Expansion: Once the RDE(s) is established for DS-6157a (Part 1), enrollment in Dose Expansion (Part 2) will commence in 2 cohorts. Participants with GIST who have progressed on or are intolerant to imatinib (IM) and at least one post-IM treatment will be enrolled in Cohort 1, and participants with GIST who progressed on IM and had not received a post-IM treatment (2nd line) will be enrolled in Cohort 2. The study was terminated after Dose Escalation and the study never proceeded to the Dose Expansion part.
Interventions
DRUGDS-6157a
Administered as a single agent intravenously (IV) every 3 weeks
Sponsors
Daiichi Sankyo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * At least 20 years old in Japan or 18 years old in other countries at the time of signature of the informed consent form (ICF), following local regulatory requirements * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Has histopathologically documented unresectable and/or metastatic GIST meeting the criteria below: * Dose Escalation (Part 1): Participants should meet one of the following criteria: 1. (For US sites only) Participants with GIST who have progressed on or are intolerant to imatinib (IM) and at least one post-IM treatment or who are not candidates for post-IM standard of care treatment 2. (For Japan sites only) Participants with GIST who have received all the existing standard of care treatments or who are not candidates for one or more available post-IM standard of care treatments 3. Participants with GIST who are not candidates for IM or curative intent surgical treatment (i.e., participants without activating KIT or platelet-derived growth factor receptor alpha (PDGFRa) mutations, with PDGFRa D842V mutations, or are KIT negative by local results) * Dose Expansion (Part 2) Cohort 1: Participants with GIST who have progressed on or are intolerant to IM and at least one post-IM treatment * Dose Expansion (Part 2) Cohort 2: Participants with GIST who have progressed on IM and had not received a post-IM treatment (2nd line) * Consents to provide fresh tumor biopsy tissue samples both before and on DS-6157a treatment for the measurement of GPR20 levels by immunohistochemistry and other biomarkers * Has a left ventricular ejection fraction (LVEF) ≥50% by either echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) within 28 days before study treatment * Has at least 1 measurable lesion based on RECIST Version 1.1 as assessed by the Investigator * Has adequate organ function within 7 days before the start of study treatment, defined as: 1. Platelet count ≥100,000/mm\^3 2. Hemoglobin ≥8.5 g/dL 3. Absolute neutrophil count ≥1,500/mm\^3 4. Creatinine clearance ≥50 mL/min 5. Aspartate aminotransferase ≤3 × upper limit of normal (ULN) (if liver metastases are present, ≤5 × ULN) 6. Alanine aminotransferase ≤3 × ULN (if liver metastases are present, ≤5 × ULN) 7. Total bilirubin ≤1.5 × ULN or ≤3.0 × ULN for participants with documented history of Gilbert's Syndrome * Has an adequate treatment washout period prior to start of study treatment, defined as: 1. Major surgery: ≥4 weeks (or 2 weeks for minor surgeries) 2. Radiation therapy: ≥3 weeks (or 2 weeks for palliative radiation excluding pelvic radiation) 3. Systemic anti-cancer therapy (except for anti-androgen for prostate cancer and bisphosphonate, denosumab, or medroxyprogesterone acetate for bone metastases): * Cytotoxic chemotherapy: ≥3 weeks or 5 times the terminal elimination half-life (t½) of the chemotherapeutic agent, whichever is shorter * Antibody and antibody-conjugates therapy: ≥3 weeks or 5 times the t½, whichever is longer * Prior tyrosine kinase inhibitors (TKIs): washout period from 2 to 21 days depending on the TKI * Immunotherapy: ≥4 weeks. * Male participants with female partners of childbearing potential and female participants of child-bearing potential must agree to use a highly effective form of contraception, or avoid intercourse during and upon completion of the study and for at least 4 months (for males) and for at least 7 months (for females) after the last dose of study drug.
Exclusion criteria
* History of an allogeneic bone marrow or solid organ transplant within 3 months before the start of study treatment * Concomitant treatment with any medication that is classified as having a known risk of Torsades de pointes should be avoided from the start of study treatment through the end of Cycle 3 * Prophylactic administration of granulocyte colony-stimulating factor (G-CSF), filgrastim, pegfilgrastim, erythropoietin, or the transfusion of blood, red blood cells, or platelets within 14 days before the start of treatment and during Cycle 1. Chronic therapy with erythropoietin at stable dose that started at least 14 days before the first dose of DS-6157a may continue. * Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, Grade ≤1. Participants with chronic Grade 2 toxicities may be eligible. * Has spinal cord compression or clinically active central nervous system (CNS) metastases (including brain metastases), defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms * Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product * Has a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety, efficacy, or any other assessments of the investigational regimen * Has a documented history of myocardial infarction or unstable angina within 6 months before study treatment * Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment * Has a corrected QT by Fridericia's formula (QTcF), of \>470 ms based on the average of triplicate 12-lead electrocardiogram (ECG) per local read * Has a documented history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening * Has clinically significant pulmonary compromise or requirement for supplemental oxygen * Has clinically significant corneal disease * Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals * Has active human immunodeficiency virus (HIV) infection as determined by plasma HIV RNA viral load. * Has evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, as manifest by the detectable viral load (HBV-DNA or HCV-RNA, respectively) * Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days before study treatment * Women who plan to become pregnant while in the study and for at least 7 months after the last administration of study treatment * Men who plan to father a child while in the study and for at least 4 months after the last administration of study treatment * Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, substance abuse, or other medical condition that would increase the risk of toxicity or interfere with participation of the participant or evaluation of the clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Cycle 1 Day 1 to Day 21 (each cycle is 21 days) | For hematologic toxicities, a DLT is defined as: Grade (Gr) 4 neutrophil count decreased lasting \>7 days, Gr ≥3 febrile neutropenia, Gr ≥3 anemia requiring transfusion, Gr 4 anemia, Gr 4 platelet count decreased, Gr ≥3 platelet count decreased lasting \>7 days or associated with clinically significant hemorrhage and/or requiring transfusion, and Gr 4 lymphocyte count decreased lasting ≥14 days. For non-hematologic, non-hepatic major organ toxicities, a DLT is all TEAEs of Gr ≥3 except: Gr 3 fatigue lasting \<7 days, Gr 3 nausea, vomiting, diarrhea, or anorexia that has resolved to Gr ≤2 within 3 days with maximal medical management, Gr 3 isolated lab findings not associated with signs or symptoms including alkaline phosphatase increased, hyperuricemia, serum amylase increased, and lipase increased, and Gr 3 hyponatremia lasting \<72 hours developed from Gr 1 at baseline. Symptomatic Gr 4 events were considered DLTs unless there was evidence it was associated with disease progression. |
| Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Baseline up to 30 days after end of treatment, up to approximately 1 year 10 months post-treatment | Treatment-emergent AEs (TEAEs) are adverse events with an onset date during the on-treatment period. Adverse events will be graded according to NCI CTCAE Version 5.0 and coded using the current version of Medical Dictionary for Regulatory Activities (MedDRA) version 24.1. |
| Objective Response Rate (ORR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | Baseline up to 5 years post-treatment | — |
| Duration of Response (DoR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | Baseline up to 5 years post-treatment | — |
| Disease Control Rate (DCR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | Baseline up to 5 years post-treatment | — |
| Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | Baseline up to 5 years post-treatment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) | The plasma PK parameters were estimated using standard noncompartmental methods. |
| Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) | The plasma PK parameters were estimated using standard noncompartmental methods. |
| Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) | The plasma PK parameters were estimated using standard noncompartmental methods. |
| Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) | The plasma PK parameters were estimated using standard noncompartmental methods. |
| Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Baseline up to long-term follow up (defined as until the start of a new anti-cancer treatment, PD, death, lost to follow up, withdrawal of consent, or at the discretion of the Investigator, whichever occurs first), up to approximately 1 year 10 months. | Based on Response Evaluation Criteria In Solid Tumors guidelines, complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions). |
| Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) | The plasma PK parameters were estimated using standard noncompartmental methods. |
| Objective Response Rate (ORR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Baseline up to 5 years post-treatment | — |
| Duration of Response (DoR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Baseline up to 5 years post-treatment | — |
| Disease Control Rate (DCR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Baseline up to 5 years post-treatment | — |
| Number of Participants With Anti-drug Antibodies Against DS-6157a Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) | Baseline up to 5 years post-treatment | — |
| Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Baseline up to the date of the first documented radiological progression or death due to any cause, whichever occurs first, up to approximately 1 year 10 months | Progression-free survival (PFS) is defined as the time from randomization/start of study treatment to the date of event defined as the first documented radiological progression or death due to any cause. |
| Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) | The plasma PK parameters were estimated using standard noncompartmental methods. |
| Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) | The plasma PK parameters were estimated using standard noncompartmental methods. |
| Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) | The plasma PK parameters were estimated using standard noncompartmental methods. |
| Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) | The plasma PK parameters were estimated using standard noncompartmental methods. |
| Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) | The plasma PK parameters were estimated using standard noncompartmental methods. |
Countries
Japan, United States
Participant flow
Recruitment details
A total of 34 participants who met all inclusion and no exclusion criteria were enrolled and received treatment at 5 clinic sites in the United States and Japan.
Pre-assignment details
Dose Escalation (Part 1) was designed to establish the maximum tolerated dose and recommended dose of expansion (RDE) for DS-6157a. Dose-Expansion (Part 2) was expected to start at the RDE to further characterize the safety and tolerability, pharmacokinetics profile, and efficacy of DS-6157a; however, due to lower than anticipated efficacy in Part 1, the Sponsor decided to terminate the study prior to Dose Expansion. Efficacy analyses were limited in Part 1; no analyses in Part 2 were conducted.
Participants by arm
| Arm | Count |
|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks. | 4 |
| Dose Escalation: DS-6157a 3.2 mg/kg Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks. | 4 |
| Dose Escalation: DS-6157a 4.8 mg/kg Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks. | 5 |
| Dose Escalation: DS-6157a 6.4 mg/kg Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks. | 13 |
| Dose Escalation: DS-6157a 9.6 mg/kg Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks. | 6 |
| Dose Escalation: DS-6157a 12.8 mg/kg Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks. | 2 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 3 | 0 | 0 |
| Overall Study | Clinical progression | 1 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 3 | 2 | 0 |
| Overall Study | Progressive disease | 3 | 3 | 4 | 5 | 1 | 2 |
| Overall Study | Withdrawal by patient | 0 | 0 | 0 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Dose Escalation: DS-6157a 3.2 mg/kg | Dose Escalation: DS-6157a 4.8 mg/kg | Dose Escalation: DS-6157a 6.4 mg/kg | Dose Escalation: DS-6157a 9.6 mg/kg | Dose Escalation: DS-6157a 12.8 mg/kg | Dose Escalation: DS-6157a 1.6 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 2 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 11 Participants | 3 Participants | 2 Participants | 2 Participants | 23 Participants |
| Age, Continuous | 62.3 years STANDARD_DEVIATION 17.4 | 60.8 years STANDARD_DEVIATION 10.3 | 58.4 years STANDARD_DEVIATION 13 | 55.8 years STANDARD_DEVIATION 12.9 | 53.0 years STANDARD_DEVIATION 9.9 | 57.3 years STANDARD_DEVIATION 14.4 | 58.3 years STANDARD_DEVIATION 12.4 |
| Race/Ethnicity, Customized American Indian or Alaska Native Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 7 Participants | 2 Participants | 0 Participants | 3 Participants | 16 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 3 Participants | 6 Participants | 3 Participants | 2 Participants | 0 Participants | 16 Participants |
| Region of Enrollment Japan | 2 participants | 2 participants | 7 participants | 2 participants | 0 participants | 3 participants | 16 participants |
| Region of Enrollment United States | 2 participants | 3 participants | 6 participants | 4 participants | 2 participants | 1 participants | 18 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 6 Participants | 3 Participants | 1 Participants | 1 Participants | 15 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 7 Participants | 3 Participants | 1 Participants | 3 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 4 | 0 / 4 | 2 / 5 | 2 / 13 | 1 / 6 | 0 / 2 |
| other Total, other adverse events | 4 / 4 | 4 / 4 | 5 / 5 | 13 / 13 | 6 / 6 | 2 / 2 |
| serious Total, serious adverse events | 1 / 4 | 1 / 4 | 1 / 5 | 2 / 13 | 3 / 6 | 1 / 2 |
Outcome results
Primary
Disease Control Rate (DCR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion)
Time frame: Baseline up to 5 years post-treatment
Population: This outcome measure was not assessed due to early study termination.
Primary
Duration of Response (DoR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion)
Time frame: Baseline up to 5 years post-treatment
Population: This outcome measure was not assessed due to early study termination.
Primary
Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
For hematologic toxicities, a DLT is defined as: Grade (Gr) 4 neutrophil count decreased lasting \>7 days, Gr ≥3 febrile neutropenia, Gr ≥3 anemia requiring transfusion, Gr 4 anemia, Gr 4 platelet count decreased, Gr ≥3 platelet count decreased lasting \>7 days or associated with clinically significant hemorrhage and/or requiring transfusion, and Gr 4 lymphocyte count decreased lasting ≥14 days. For non-hematologic, non-hepatic major organ toxicities, a DLT is all TEAEs of Gr ≥3 except: Gr 3 fatigue lasting \<7 days, Gr 3 nausea, vomiting, diarrhea, or anorexia that has resolved to Gr ≤2 within 3 days with maximal medical management, Gr 3 isolated lab findings not associated with signs or symptoms including alkaline phosphatase increased, hyperuricemia, serum amylase increased, and lipase increased, and Gr 3 hyponatremia lasting \<72 hours developed from Gr 1 at baseline. Symptomatic Gr 4 events were considered DLTs unless there was evidence it was associated with disease progression.
Time frame: Cycle 1 Day 1 to Day 21 (each cycle is 21 days)
Population: Dose-limiting toxicities were assessed in the Dose Limiting Toxicity Evaluable Set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | 2 Participants |
Primary
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Treatment-emergent AEs (TEAEs) are adverse events with an onset date during the on-treatment period. Adverse events will be graded according to NCI CTCAE Version 5.0 and coded using the current version of Medical Dictionary for Regulatory Activities (MedDRA) version 24.1.
Time frame: Baseline up to 30 days after end of treatment, up to approximately 1 year 10 months post-treatment
Population: Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Epistaxis | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Mucosal inflammation | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Intestinal perforation | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sinus tachycardia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Delirium | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vomiting | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypotension | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Oedema peripheral | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Chest discomfort | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hot flush | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Platelet count decreased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Confusional state | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Constipation | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pyrexia | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea exertional | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash papular | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood creatinine increased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anxiety | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Tachycardia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hepatic function abnormal | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Injection site reaction | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Skin fissures | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Taste disorder | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypokalaemia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Peripheral sensory neuropathy | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal hypertension | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alopecia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperuricaemia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperaesthesia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspepsia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal vein thrombosis | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypothyroidism | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood potassium decreased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Cough | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Protein total decreased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pelvic pain | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Bronchitis | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypocalcaemia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Any TEAE | 4 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Headache | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Varices oesophageal | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye disorder | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | COVID-19 | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Palpitations | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Deep vein thrombosis | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperhidrosis | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysgeusia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperphosphataemia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye infection | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Urinary tract obstruction | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Diarrhea | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lacrimation increased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysarthria | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastrooesophageal reflux disease | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Herpes zoster | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fatigue | 3 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sleep apnoea syndrome | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dizziness | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Asthenia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Disturbance in attention | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pneumonia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperkalaemia | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Malaise | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vitreous floaters | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Myalgia | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flatulence | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper respiratory tract infection | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Weight decreased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anemia | 3 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Influenza like illness | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Renal disorder | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lymphocyte count decreased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Contusion | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash maculo-papular | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal distension | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscular weakness | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper gastrointestinal haemorrhage | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutropenia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fall | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypertension | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rhinorrhoea | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperglycaemia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle spasms | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Proteinuria | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Infusion related reaction | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyponatraemia | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle fatigue | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | White blood cell count decreased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flank pain | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Procedural pain | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoglycaemia | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pulmonary embolism | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Ascites | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Back pain | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anal fissure | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alanine aminotransferase increased | 2 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pollakiuria | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Febrile neutropenia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutrophil count decreased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Arthritis | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastritis | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Aspartate aminotransferase increased | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain lower | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dehydration | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematemesis | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematuria | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Decreased appetite | 3 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood albumin decreased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Insomnia | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain upper | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Athralgia | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Nausea | 3 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Electrocardiogram QT prolonged | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood alkaline phosphatase increased | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dry skin | 1 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hiccups | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoalbuminaemia | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypophosphataemia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flank pain | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood creatinine increased | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypokalaemia | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood potassium decreased | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoglycaemia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Electrocardiogram QT prolonged | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutropenia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypocalcaemia | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lymphocyte count decreased | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fatigue | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Intestinal perforation | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoalbuminaemia | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastrooesophageal reflux disease | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutrophil count decreased | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Platelet count decreased | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperuricaemia | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperphosphataemia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Protein total decreased | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperkalaemia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Weight decreased | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Palpitations | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperglycaemia | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Ascites | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | White blood cell count decreased | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperhidrosis | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dehydration | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Decreased appetite | 2 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Epistaxis | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematemesis | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Injection site reaction | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sinus tachycardia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea exertional | 2 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hot flush | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Tachycardia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Cough | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypothyroidism | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pelvic pain | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Asthenia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye disorder | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Urinary tract obstruction | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lacrimation increased | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Renal disorder | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vitreous floaters | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Constipation | 2 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Malaise | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal distension | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Proteinuria | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypertension | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain | 2 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash papular | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pollakiuria | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematuria | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain lower | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dry skin | 2 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Insomnia | 2 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain upper | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vomiting | 2 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Delirium | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Diarrhea | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Mucosal inflammation | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Influenza like illness | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Oedema peripheral | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypotension | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Confusional state | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pyrexia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anxiety | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Taste disorder | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hepatic function abnormal | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alopecia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Peripheral sensory neuropathy | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal hypertension | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperaesthesia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal vein thrombosis | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash maculo-papular | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Varices oesophageal | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Headache | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspepsia | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Bronchitis | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Any TEAE | 4 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | COVID-19 | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysgeusia | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anal fissure | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye infection | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sleep apnoea syndrome | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysarthria | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dizziness | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Herpes zoster | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Disturbance in attention | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pneumonia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rhinorrhoea | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Myalgia | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper respiratory tract infection | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper gastrointestinal haemorrhage | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscular weakness | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flatulence | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Contusion | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anemia | 2 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Deep vein thrombosis | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fall | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle spasms | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle fatigue | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Infusion related reaction | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pulmonary embolism | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyponatraemia | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Procedural pain | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Back pain | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alanine aminotransferase increased | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Arthritis | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Aspartate aminotransferase increased | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Febrile neutropenia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Nausea | 3 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Athralgia | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastritis | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood albumin decreased | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Skin fissures | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Chest discomfort | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood alkaline phosphatase increased | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hiccups | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypophosphataemia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypothyroidism | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Skin fissures | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Deep vein thrombosis | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hot flush | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypertension | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypotension | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Influenza like illness | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Any TEAE | 5 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anemia | 4 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Febrile neutropenia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anal fissure | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutropenia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Palpitations | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sinus tachycardia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Injection site reaction | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Tachycardia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye disorder | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lacrimation increased | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vitreous floaters | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal distension | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Malaise | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain lower | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain upper | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Mucosal inflammation | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Diarrhea | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Oedema peripheral | 3 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pyrexia | 2 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hepatic function abnormal | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal hypertension | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal vein thrombosis | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Bronchitis | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspepsia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | COVID-19 | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye infection | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Herpes zoster | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pneumonia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper respiratory tract infection | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Contusion | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flatulence | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fall | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Infusion related reaction | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Procedural pain | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alanine aminotransferase increased | 2 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Aspartate aminotransferase increased | 2 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood albumin decreased | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastritis | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood alkaline phosphatase increased | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood creatinine increased | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood potassium decreased | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Electrocardiogram QT prolonged | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lymphocyte count decreased | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutrophil count decreased | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastrooesophageal reflux disease | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Platelet count decreased | 2 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Protein total decreased | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Weight decreased | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | White blood cell count decreased | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Decreased appetite | 4 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dehydration | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematemesis | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperglycaemia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperkalaemia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperphosphataemia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Ascites | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperuricaemia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoalbuminaemia | 2 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypocalcaemia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Intestinal perforation | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoglycaemia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypokalaemia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyponatraemia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypophosphataemia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Athralgia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Arthritis | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Nausea | 3 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Back pain | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flank pain | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle fatigue | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle spasms | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscular weakness | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Myalgia | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper gastrointestinal haemorrhage | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Disturbance in attention | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dizziness | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysarthria | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysgeusia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Headache | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperaesthesia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Varices oesophageal | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Peripheral sensory neuropathy | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Taste disorder | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anxiety | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Confusional state | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Delirium | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Insomnia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vomiting | 2 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematuria | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pollakiuria | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Proteinuria | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Renal disorder | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Urinary tract obstruction | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pelvic pain | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Asthenia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Cough | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea exertional | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Constipation | 2 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Epistaxis | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hiccups | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pulmonary embolism | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Chest discomfort | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rhinorrhoea | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sleep apnoea syndrome | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alopecia | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dry skin | 3 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperhidrosis | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash maculo-papular | 1 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fatigue | 3 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash papular | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Ascites | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood alkaline phosphatase increased | 2 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Febrile neutropenia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypophosphataemia | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood albumin decreased | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Athralgia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Aspartate aminotransferase increased | 3 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alanine aminotransferase increased | 3 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Arthritis | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Procedural pain | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pulmonary embolism | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Back pain | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Nausea | 11 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flank pain | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Infusion related reaction | 3 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flatulence | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle fatigue | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fall | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anemia | 6 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle spasms | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Contusion | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Influenza like illness | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscular weakness | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper respiratory tract infection | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pneumonia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash maculo-papular | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Myalgia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rhinorrhoea | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Disturbance in attention | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper gastrointestinal haemorrhage | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Herpes zoster | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Chest discomfort | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dizziness | 4 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye infection | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysarthria | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspepsia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | COVID-19 | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Any TEAE | 13 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysgeusia | 2 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Bronchitis | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Headache | 4 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal vein thrombosis | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal hypertension | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sleep apnoea syndrome | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperaesthesia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anal fissure | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Peripheral sensory neuropathy | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Varices oesophageal | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hepatic function abnormal | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Taste disorder | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pyrexia | 4 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypotension | 2 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anxiety | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Diarrhea | 3 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Oedema peripheral | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash papular | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Confusional state | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Mucosal inflammation | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alopecia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Delirium | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain upper | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Insomnia | 2 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Constipation | 5 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain lower | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Malaise | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematuria | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vomiting | 4 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain | 2 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypertension | 2 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pollakiuria | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal distension | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Proteinuria | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vitreous floaters | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dry skin | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Renal disorder | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lacrimation increased | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye disorder | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Urinary tract obstruction | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypothyroidism | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pelvic pain | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hot flush | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fatigue | 6 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Injection site reaction | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Cough | 3 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Asthenia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Tachycardia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Skin fissures | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea | 3 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sinus tachycardia | 2 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperhidrosis | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea exertional | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Decreased appetite | 6 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | White blood cell count decreased | 3 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dehydration | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Weight decreased | 2 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperglycaemia | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematemesis | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Palpitations | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperkalaemia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Protein total decreased | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastrooesophageal reflux disease | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperphosphataemia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Epistaxis | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Platelet count decreased | 4 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperuricaemia | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutrophil count decreased | 5 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoalbuminaemia | 2 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lymphocyte count decreased | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Electrocardiogram QT prolonged | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutropenia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypocalcaemia | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood potassium decreased | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Deep vein thrombosis | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoglycaemia | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Intestinal perforation | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hiccups | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypokalaemia | 2 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood creatinine increased | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastritis | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyponatraemia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyponatraemia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood alkaline phosphatase increased | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Malaise | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain lower | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alopecia | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypophosphataemia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood albumin decreased | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | White blood cell count decreased | 5 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Aspartate aminotransferase increased | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Influenza like illness | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Insomnia | 2 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Athralgia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lymphocyte count decreased | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alanine aminotransferase increased | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea exertional | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anemia | 3 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutropenia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Arthritis | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fatigue | 2 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Procedural pain | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypertension | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dehydration | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematuria | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Back pain | 2 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperhidrosis | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flatulence | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Infusion related reaction | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pulmonary embolism | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flank pain | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Nausea | 6 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Weight decreased | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypokalaemia | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash papular | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Palpitations | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle fatigue | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Ascites | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fall | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pollakiuria | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vomiting | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal distension | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle spasms | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Contusion | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoalbuminaemia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper respiratory tract infection | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Skin fissures | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperglycaemia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscular weakness | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Proteinuria | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pneumonia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vitreous floaters | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoglycaemia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lacrimation increased | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Myalgia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastrooesophageal reflux disease | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anal fissure | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Herpes zoster | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rhinorrhoea | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Protein total decreased | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Disturbance in attention | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Renal disorder | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Electrocardiogram QT prolonged | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspepsia | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye disorder | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Intestinal perforation | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dizziness | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper gastrointestinal haemorrhage | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye infection | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dry skin | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Any TEAE | 6 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperkalaemia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysarthria | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Urinary tract obstruction | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | COVID-19 | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Injection site reaction | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypothyroidism | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematemesis | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysgeusia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Bronchitis | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hot flush | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal vein thrombosis | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash maculo-papular | 2 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastritis | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Headache | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pelvic pain | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal hypertension | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood creatinine increased | 2 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Deep vein thrombosis | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypocalcaemia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperaesthesia | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sleep apnoea syndrome | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Constipation | 2 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hepatic function abnormal | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Chest discomfort | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperphosphataemia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Peripheral sensory neuropathy | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Cough | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Febrile neutropenia | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Diarrhea | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypotension | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Tachycardia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Taste disorder | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Varices oesophageal | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pyrexia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Platelet count decreased | 5 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood potassium decreased | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Epistaxis | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anxiety | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea | 2 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Oedema peripheral | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Asthenia | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sinus tachycardia | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hiccups | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Confusional state | 1 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Mucosal inflammation | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperuricaemia | 2 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain upper | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutrophil count decreased | 4 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Decreased appetite | 4 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Delirium | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperaesthesia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anal fissure | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Ascites | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Constipation | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Diarrhea | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspepsia | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flatulence | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastritis | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Gastrooesophageal reflux disease | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematemesis | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Intestinal perforation | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Nausea | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper gastrointestinal haemorrhage | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Varices oesophageal | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vomiting | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Asthenia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Chest discomfort | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fatigue | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Influenza like illness | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Injection site reaction | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Malaise | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Mucosal inflammation | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Oedema peripheral | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pyrexia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hepatic function abnormal | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal hypertension | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Portal vein thrombosis | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Bronchitis | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | COVID-19 | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye infection | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Herpes zoster | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pneumonia | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Upper respiratory tract infection | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Contusion | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Fall | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Infusion related reaction | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Procedural pain | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alanine aminotransferase increased | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Aspartate aminotransferase increased | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood albumin decreased | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood alkaline phosphatase increased | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood creatinine increased | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Blood potassium decreased | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Electrocardiogram QT prolonged | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lymphocyte count decreased | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutrophil count decreased | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Platelet count decreased | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Protein total decreased | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Weight decreased | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | White blood cell count decreased | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Decreased appetite | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dehydration | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperglycaemia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperkalaemia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperphosphataemia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperuricaemia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoalbuminaemia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypocalcaemia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypoglycaemia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypokalaemia | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyponatraemia | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypophosphataemia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Athralgia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Arthritis | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Back pain | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Flank pain | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle fatigue | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscle spasms | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Muscular weakness | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Myalgia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Disturbance in attention | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dizziness | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysarthria | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dysgeusia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Headache | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain upper | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Peripheral sensory neuropathy | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Taste disorder | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anxiety | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Confusional state | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Delirium | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Insomnia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Haematuria | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pollakiuria | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Proteinuria | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Renal disorder | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Urinary tract obstruction | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pelvic pain | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Cough | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dyspnoea exertional | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Epistaxis | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hiccups | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Pulmonary embolism | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rhinorrhoea | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sleep apnoea syndrome | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Alopecia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Dry skin | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hyperhidrosis | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash maculo-papular | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Rash papular | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Skin fissures | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Deep vein thrombosis | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hot flush | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypertension | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypotension | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Any TEAE | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Anemia | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Febrile neutropenia | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Neutropenia | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Palpitations | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Sinus tachycardia | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Tachycardia | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Hypothyroidism | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Eye disorder | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Lacrimation increased | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Vitreous floaters | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal distension | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Abdominal pain lower | 0 Participants |
Primary
Objective Response Rate (ORR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion)
Time frame: Baseline up to 5 years post-treatment
Population: This outcome measure was not assessed due to early study termination.
Primary
Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion)
Time frame: Baseline up to 5 years post-treatment
Population: This outcome measure was not assessed due to early study termination.
Secondary
Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
Based on Response Evaluation Criteria In Solid Tumors guidelines, complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions).
Time frame: Baseline up to long-term follow up (defined as until the start of a new anti-cancer treatment, PD, death, lost to follow up, withdrawal of consent, or at the discretion of the Investigator, whichever occurs first), up to approximately 1 year 10 months.
Population: Best overall response was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Stable disease (SD) | 2 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Partial response (PR) | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Complete response (CR) | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Not evaluable (NE) | 0 Participants |
| Dose Escalation: DS-6157a 1.6 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Progressive disease (PD) | 2 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Not evaluable (NE) | 1 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Complete response (CR) | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Partial response (PR) | 0 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Stable disease (SD) | 3 Participants |
| Dose Escalation: DS-6157a 3.2 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Progressive disease (PD) | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Partial response (PR) | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Progressive disease (PD) | 2 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Complete response (CR) | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Not evaluable (NE) | 0 Participants |
| Dose Escalation: DS-6157a 4.8 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Stable disease (SD) | 3 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Stable disease (SD) | 7 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Progressive disease (PD) | 3 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Partial response (PR) | 1 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Complete response (CR) | 0 Participants |
| Dose Escalation: DS-6157a 6.4 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Not evaluable (NE) | 2 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Not evaluable (NE) | 3 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Partial response (PR) | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Stable disease (SD) | 2 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Complete response (CR) | 0 Participants |
| Dose Escalation: DS-6157a 9.6 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Progressive disease (PD) | 1 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Complete response (CR) | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Not evaluable (NE) | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Partial response (PR) | 0 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Progressive disease (PD) | 2 Participants |
| Dose Escalation: DS-6157a 12.8 mg/kg | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Stable disease (SD) | 0 Participants |
Secondary
Disease Control Rate (DCR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
Time frame: Baseline up to 5 years post-treatment
Population: This outcome measure was not assessed due to early study termination.
Secondary
Duration of Response (DoR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
Time frame: Baseline up to 5 years post-treatment
Population: This outcome measure was not assessed due to early study termination.
Secondary
Number of Participants With Anti-drug Antibodies Against DS-6157a Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST)
Time frame: Baseline up to 5 years post-treatment
Population: This outcome measure was not assessed due to early study termination.
Secondary
Objective Response Rate (ORR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
Time frame: Baseline up to 5 years post-treatment
Population: This outcome measure was not assessed due to early study termination.
Secondary
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
The plasma PK parameters were estimated using standard noncompartmental methods.
Time frame: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 250 day*ug/mL | Standard Deviation 36.8 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 181 day*ug/mL | Standard Deviation 18.3 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 251 day*ug/mL | Standard Deviation 31.1 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 176 day*ug/mL | Standard Deviation 22.8 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 427 day*ug/mL | Standard Deviation 182 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 718 day*ug/mL | Standard Deviation 35.1 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 400 day*ug/mL | Standard Deviation 157 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 691 day*ug/mL | Standard Deviation 24.6 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 549 day*ug/mL | Standard Deviation 113 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 780 day*ug/mL | Standard Deviation 342 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 733 day*ug/mL | Standard Deviation 344 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 512 day*ug/mL | Standard Deviation 67.1 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 1430 day*ug/mL | Standard Deviation 458 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 781 day*ug/mL | Standard Deviation 363 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 821 day*ug/mL | Standard Deviation 371 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 1460 day*ug/mL | Standard Deviation 538 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 2400 day*ug/mL | Standard Deviation 240 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 2270 day*ug/mL | Standard Deviation 60.8 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 1570 day*ug/mL | Standard Deviation 401 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 1570 day*ug/mL | Standard Deviation 394 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 1690 day*ug/mL | Standard Deviation 499 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 1590 day*ug/mL | Standard Deviation 388 |
Secondary
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a
The plasma PK parameters were estimated using standard noncompartmental methods.
Time frame: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 6.85 day*ng/mL | Standard Deviation 2.16 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 6.48 day*ng/mL | Standard Deviation 0.52 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 21.8 day*ng/mL | Standard Deviation 3.86 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 19.7 day*ng/mL | Standard Deviation 4.01 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 27.6 day*ng/mL | Standard Deviation 5.07 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 20.4 day*ng/mL | Standard Deviation 5.55 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 70.7 day*ng/mL | Standard Deviation 61.1 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 49.5 day*ng/mL | Standard Deviation 23.5 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 66.9 day*ng/mL | Standard Deviation 25 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 69.1 day*ng/mL | Standard Deviation 30.7 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 98.5 day*ng/mL | Standard Deviation 18.5 |
Secondary
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
The plasma PK parameters were estimated using standard noncompartmental methods.
Time frame: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 181 day*ug/mL | Standard Deviation 18.2 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 223 day*ug/mL | Standard Deviation 76.6 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 176 day*ug/mL | Standard Deviation 22.6 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 218 day*ug/mL | Standard Deviation 76.9 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 761 day*ug/mL | Standard Deviation 47.3 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 731 day*ug/mL | Standard Deviation 40.4 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 399 day*ug/mL | Standard Deviation 178 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 425 day*ug/mL | Standard Deviation 203 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 676 day*ug/mL | Standard Deviation 428 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 549 day*ug/mL | Standard Deviation 111 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 733 day*ug/mL | Standard Deviation 425 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 574 day*ug/mL | Standard Deviation 150 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 776 day*ug/mL | Standard Deviation 346 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 1520 day*ug/mL | Standard Deviation 654 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 1570 day*ug/mL | Standard Deviation 746 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 730 day*ug/mL | Standard Deviation 349 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 2450 day*ug/mL | Standard Deviation 217 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 1530 day*ug/mL | Standard Deviation 495 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 2570 day*ug/mL | Standard Deviation 11.9 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 1530 day*ug/mL | Standard Deviation 507 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 1980 day*ug/mL | Standard Deviation 256 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 2140 day*ug/mL | Standard Deviation 351 |
Secondary
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a
The plasma PK parameters were estimated using standard noncompartmental methods.
Time frame: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 6.85 day*ng/mL | Standard Deviation 2.16 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 5.95 day*ng/mL | Standard Deviation 0.94 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 22.3 day*ng/mL | Standard Deviation 3.58 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 19 day*ng/mL | Standard Deviation 2.49 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 22.8 day*ng/mL | Standard Deviation 10.4 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 20.5 day*ng/mL | Standard Deviation 5.53 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 75.9 day*ng/mL | Standard Deviation 55.9 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 51.8 day*ng/mL | Standard Deviation 23.8 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 70.6 day*ng/mL | Standard Deviation 30.4 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 74.8 day*ng/mL | Standard Deviation 30.2 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 111 day*ng/mL | Standard Deviation 27.9 |
Secondary
Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
The plasma PK parameters were estimated using standard noncompartmental methods.
Time frame: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 3.09 ug/mL | Standard Deviation 0.57 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 5.1 ug/mL | Standard Deviation 1.87 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 3.54 ug/mL | Standard Deviation 0.84 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 6.32 ug/mL | Standard Deviation 0.87 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 14.7 ug/mL | Standard Deviation 1.68 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 11.7 ug/mL | Standard Deviation 6.05 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 9.1 ug/mL | Standard Deviation 2.16 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 8.96 ug/mL | Standard Deviation 0.36 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 23 ug/mL | Standard Deviation 9.76 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 8.93 ug/mL | Standard Deviation 4.9 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 21 ug/mL | Standard Deviation 8.6 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 13.9 ug/mL | Standard Deviation 12.9 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 15.8 ug/mL | Standard Deviation 9.27 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 28.6 ug/mL | Standard Deviation 7.21 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 30 ug/mL | Standard Deviation 10 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 14.3 ug/mL | Standard Deviation 10.1 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 58.8 ug/mL | Standard Deviation 13.2 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 24.3 ug/mL | Standard Deviation 12.6 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 52.8 ug/mL | Standard Deviation 12 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 27.9 ug/mL | Standard Deviation 13.6 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 6.45 ug/mL | Standard Deviation 4.82 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 7.16 ug/mL | Standard Deviation 6 |
Secondary
Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a
The plasma PK parameters were estimated using standard noncompartmental methods.
Time frame: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 0.05 ng/mL | Standard Deviation 0.01 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 0.07 ng/mL | Standard Deviation 0.01 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 0.18 ng/mL | Standard Deviation 0.03 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 0.13 ng/mL | Standard Deviation 0.03 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 0.37 ng/mL | Standard Deviation 0.21 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 0.17 ng/mL | Standard Deviation 0.1 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 1.16 ng/mL | Standard Deviation 1.4 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 0.41 ng/mL | Standard Deviation 0.35 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 0.65 ng/mL | Standard Deviation 0.27 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 0.54 ng/mL | Standard Deviation 0.28 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 0.16 ng/mL | Standard Deviation 0.2 |
Secondary
Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
The plasma PK parameters were estimated using standard noncompartmental methods.
Time frame: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 32.3 ug/mL | Standard Deviation 4.01 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 37 ug/mL | Standard Deviation 0.55 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 32.3 ug/mL | Standard Deviation 1.89 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 35.2 ug/mL | Standard Deviation 2.38 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 90.8 ug/mL | Standard Deviation 13.8 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 89.9 ug/mL | Standard Deviation 15.1 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 71.4 ug/mL | Standard Deviation 15.7 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 78.8 ug/mL | Standard Deviation 23.3 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 111 ug/mL | Standard Deviation 12.4 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 98.6 ug/mL | Standard Deviation 7.62 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 118 ug/mL | Standard Deviation 16.8 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 100 ug/mL | Standard Deviation 6.1 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 142 ug/mL | Standard Deviation 28.7 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 162 ug/mL | Standard Deviation 51.9 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 160 ug/mL | Standard Deviation 42.9 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 137 ug/mL | Standard Deviation 33.7 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 267 ug/mL | Standard Deviation 48.1 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 237 ug/mL | Standard Deviation 26.2 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 280 ug/mL | Standard Deviation 47.4 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 227 ug/mL | Standard Deviation 33.7 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 279 ug/mL | Standard Deviation 61.5 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 291 ug/mL | Standard Deviation 88.4 |
Secondary
Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a
The plasma PK parameters were estimated using standard noncompartmental methods.
Time frame: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 1.12 ng/mL | Standard Deviation 0.25 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 1.5 ng/mL | Standard Deviation 0.88 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 3.48 ng/mL | Standard Deviation 1.18 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 4.51 ng/mL | Standard Deviation 2.03 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 4 ng/mL | Standard Deviation 1.19 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 4.78 ng/mL | Standard Deviation 1.35 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 12.8 ng/mL | Standard Deviation 11.4 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 9.76 ng/mL | Standard Deviation 5.13 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 7.92 ng/mL | Standard Deviation 1.4 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 14.6 ng/mL | Standard Deviation 3.36 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 19.4 ng/mL | Standard Deviation 1.2 |
Secondary
Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
The plasma PK parameters were estimated using standard noncompartmental methods.
Time frame: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 9.1 day | Standard Deviation 5.38 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 9.05 day | Standard Deviation 1.02 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 9.35 day | Standard Deviation 2.08 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 10.7 day | Standard Deviation 3.49 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 5.45 day | Standard Deviation 1.8 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 5.05 day | Standard Deviation 1.23 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 4.29 day | Standard Deviation 1.29 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 5.67 day | Standard Deviation 1.06 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 12.8 day | Standard Deviation 4 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 8.49 day | Standard Deviation 3.61 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 10 day | Standard Deviation 4.24 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 8.37 day | Standard Deviation 4.91 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 5.35 day | Standard Deviation 1.39 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 9.47 day | Standard Deviation 3.45 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 6.37 day | Standard Deviation 1.32 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 13.2 day | Standard Deviation 9.28 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 9.73 day | Standard Deviation 3.27 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 9.61 day | Standard Deviation 5.52 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 6.52 day | Standard Deviation 3.59 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 14.7 day | Standard Deviation 2.64 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 9.69 day | Standard Deviation 4.5 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 10 day | Standard Deviation 4.61 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 7.72 day | Standard Deviation 1.71 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 14.4 day | Standard Deviation 1.66 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 6.67 day | Standard Deviation 1.98 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 7.58 day | Standard Deviation 2.01 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 11.2 day | Standard Deviation 3.95 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 7.94 day | Standard Deviation 2.73 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 12.7 day | Standard Deviation 4.03 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 4.73 day | Standard Deviation 0.59 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 7.27 day | Standard Deviation 2.77 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 11.8 day | Standard Deviation 4.72 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 2.7 day | Standard Deviation 1.52 |
Secondary
Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
The plasma PK parameters were estimated using standard noncompartmental methods.
Time frame: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 1.24 hours | Standard Deviation 0.99 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 2.59 hours | Standard Deviation 1.04 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 2.17 hours | Standard Deviation 0.96 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 1.81 hours | Standard Deviation 1.02 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 11.52 hours | Standard Deviation 9.85 |
| Dose Escalation: DS-6157a 1.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 10.5 hours | Standard Deviation 8.36 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 7.26 hours | Standard Deviation 2.62 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 18.61 hours | Standard Deviation 23.73 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 3.75 hours | Standard Deviation 1.23 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 3.06 hours | Standard Deviation 1.84 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 4.24 hours | Standard Deviation 3.45 |
| Dose Escalation: DS-6157a 3.2 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 2.09 hours | Standard Deviation 0.83 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 11.1 hours | Standard Deviation 8.96 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 2.36 hours | Standard Deviation 0.83 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 10.59 hours | Standard Deviation 8.32 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 2.07 hours | Standard Deviation 1.65 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 2.75 hours | Standard Deviation 1.53 |
| Dose Escalation: DS-6157a 4.8 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 2.07 hours | Standard Deviation 1.65 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 8.42 hours | Standard Deviation 7.16 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 2.58 hours | Standard Deviation 2.48 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 2.53 hours | Standard Deviation 1.26 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 2.71 hours | Standard Deviation 1.54 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 19.63 hours | Standard Deviation 13.53 |
| Dose Escalation: DS-6157a 6.4 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 4.96 hours | Standard Deviation 7.82 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 3 | 15.72 hours | Standard Deviation 11.79 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 2.86 hours | Standard Deviation 2.82 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 3 | 4.05 hours | Standard Deviation 4.71 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 2.62 hours | Standard Deviation 0.99 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 3 | 2.47 hours | Standard Deviation 0.12 |
| Dose Escalation: DS-6157a 9.6 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 34.17 hours | Standard Deviation 65.53 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | MAAA-1181a: Cycle 1 | 3.76 hours | Standard Deviation 0.01 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | Total anti-GPR20 antibody: Cycle 1 | 1.77 hours | Standard Deviation 0.21 |
| Dose Escalation: DS-6157a 12.8 mg/kg | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | DS-6157a: Cycle 1 | 2.7 hours | Standard Deviation 1.52 |
Secondary
Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
Progression-free survival (PFS) is defined as the time from randomization/start of study treatment to the date of event defined as the first documented radiological progression or death due to any cause.
Time frame: Baseline up to the date of the first documented radiological progression or death due to any cause, whichever occurs first, up to approximately 1 year 10 months
Population: Progression-free survival was assessed in participants with available data (events) in the Full Analysis Set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Escalation: DS-6157a 1.6 mg/kg | Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | 2.6 months |
| Dose Escalation: DS-6157a 3.2 mg/kg | Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | 6.9 months |
| Dose Escalation: DS-6157a 4.8 mg/kg | Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | 10.4 months |
| Dose Escalation: DS-6157a 6.4 mg/kg | Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | 4.2 months |
| Dose Escalation: DS-6157a 9.6 mg/kg | Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | 3.6 months |
| Dose Escalation: DS-6157a 12.8 mg/kg | Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | 1.5 months |