Cervical Cancer, Endometrial Cancer, Melanoma, Non Small Cell Lung Cancer (NSCLC), Ovarian Cancer, Sarcoma, Solid Tumors, Thyroid Cancer
Conditions
Brief summary
The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors
Detailed description
The trial consists of two parts; a dose escalation part (phase I, first in-human (FIH)) and an expansion part (phase IIa). The dose escalation part has 2 dosing schedules: 1 dose every 3 weeks (1Q3W) dose regimen, and 3 doses every 4 weeks (3Q4W) dosing regimen. The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in dose escalation part.
Interventions
BIOLOGICALEnapotamab vedotin (HuMax-AXL-ADC)
Enapotamab vedotin (HuMax-AXL-ADC) will be administered intravenously.
Sponsors
Genmab
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. For the dose escalation part: Patients with selected, relapsed or refractory solid tumors who have failed available standard therapy or who are not candidates for standard therapy. For the expansion part: Patients with advanced and/or metastatic solid tumors who are not candidates for standard therapy 2. Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST). 3. For the expansion patients must provide a tumor tissue sample from archival tissue or fresh biopsy at enrolment 4. Age ≥ 18 years. 5. Acceptable renal function 6. Acceptable liver function 7. Acceptable hematological status 8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 9. Life expectancy of at least three months. 10. Patients, both females and males, of childbearing/reproductive potential must agree to use adequate contraception while included in the trial and for six months after the last infusion of HuMax-AXL-ADC 11. Patients must provide a signed informed consent form before any trial relates activities are carried out.
Exclusion criteria
1. Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 4 weeks prior to first IMP administration. 2. Have clinically significant cardiac disease 3. Known congestive heart failure and/ or a known decreased cardiac ejection fraction of \< 45%. A baseline QT interval as corrected by Fridericia's formula (QTcF) \> 480 msec, a complete left bundle branch block (defined as a QRS interval ≥ 120 msec in left bundle branch block form) or an incomplete left bundle branch block. 4. Uncontrolled hypertension 5. Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first IMP administration. 6. Have received a cumulative dose of corticosteroid \> 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first Investigational Medicinal Product (IMP) administration. 7. History of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial. 8. Major surgery within four weeks before first IMP administration. 9. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke. 10. Any anticancer therapy including; small molecules, immunotherapy, chemotherapy monoclonal antibodies or any other experimental drug within five half-lives but maximum four weeks before first infusion. Accepted exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist. 11. Prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. 12. Radiotherapy within 14 days prior to first IMP administration. 13. Known past or current malignancy other than inclusion diagnosis, except for: * Cervical carcinoma of Stage 1B or less. * Non-invasive basal cell or squamous cell skin carcinoma. * Non-invasive, superficial bladder cancer. * Prostate cancer with a current prostate specific antigen (PSA) level \< 0.1 ng/mL. * Breast cancer in BRCA1 or BRCA2 positive ovarian cancer patients. * Any curable cancer with a complete response (CR) of \> 2 years duration. 14. Melanoma patients with an lactate dehydrogenase (LDH) ≥ 3 x upper limit normal (ULN). 15. Ongoing significant, uncontrolled medical condition including: o Serious, non-healing wound, skin ulcer (of any grade), or bone fracture. 16. Grade 2 or higher peripheral neuropathy. 17. Clinically significant active viral, bacterial or fungal infection 18. Known human immunodeficiency virus seropositivity. 19. Known positive serology for hepatitis B (unless due to vaccination or passive immunization due to immunoglobulin therapy) 20. Known positive serology for hepatitis C (unless due to immunoglobulin therapy) 21. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the trial or evaluation of the trial result 22. History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of IMP 23. Body weight \< 40 kg 24. Women who are pregnant or breast feeding. 25. Pulmonary hemorrhage or hemoptysis \> 2.5 ml blood within 6 weeks unless cause has been addressed and is medically resolved. 26. History of acute pneumonitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | From Day 1 to Day 21 of first cycle for 1Q3W dosing regimen and from Day 1 to Day 28 of first cycle for 3Q4W dosing regimen | The DLTs were defined as Grade (G) 4 neutropenia or G4 thrombocytopenia for a minimal duration of 7 days, G3 and G4 febrile neutropenia, \>=G3 hemorrhage associated with \>=G3 thrombocytopenia, G4 anemia; Stevens Johnson syndrome, toxic epidermal necrolysis, \>=G3 cutaneous vasculitis; G3 neuropathy (not improved to G1 within 3 weeks following pausing of dosing) and G4 neuropathy; G3 infusion-related reactions (IRR) that did not resolve to G1 or baseline within 24 hours; G4 IRR or G4 anaphylaxis events; \>= G3 diarrhoea and/or vomiting persisting \>48 hours or G3 nausea lasting 7 days (both despite optimal medical management); or any \>=G3 related non-hematological AEs, which occurred during the Cycle 1 and regarded as medically important as assessed by the Data Monitoring Committee (excluding Grade 3 fatigue or non-hematological laboratory abnormalities as specified in protocol). |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Day 1 through Day 1130 (maximum observed duration) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly/birth defect, is medically important, results in death, or is life-threatening. In this trial, a TEAE was defined as an AE occurring or worsening between the first dose of enapotamab vedotin and 30 days after the last dose received. |
| Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Day 1 through Day 1130 (maximum observed duration) | Number of participants with treatment-emergent infusion-related AEs and TEAEs related to enapotamab vedotin is reported. |
| Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | Day 1 through Day 1130 (maximum observed duration) | Number of participants with TEAEs of \>= Grade 3 as assessed by NCI-CTCAE v4.03 is reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. If a participant reported multiple severity grades for an AE, only the maximum grade was used. |
| Number of Participants With Grade 3 or 4 Laboratory Results | Day 1 through Day 1130 (maximum observed duration) | Number of participants with laboratory measurements graded as Grade 3 or 4 by NCI-CTCAE v 4.03 is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3 | The Tmax of conjugated enapotamab vedotin for dose-escalation part is reported. |
| Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3 | The t1/2 of conjugated enapotamab vedotin for dose-escalation part is reported. |
| Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3 | The Vss of conjugated enapotamab vedotin for dose-escalation part is reported. |
| AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3 | The AUC0-inf of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure. |
| AUC0-last of MMAE for 1Q3W Dose-escalation Part | Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3 | The AUC0-last of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure. |
| Cmax of MMAE for Dose-escalation Part | For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3 | The Cmax of MMAE for dose-escalation part is reported. |
| Total CL of MMAE in Dose-escalation Part | For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3 | The total CL of MMAE in dose-escalation part is reported. |
| t1/2 of MMAE for Dose-escalation Part | For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3 | The t1/2 of MMAE for dose-escalation part is reported. |
| Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | Day 1 through Day 1130 (Dose-escalation part: Predose of Day 1 of Cycles 1 to 12, end of treatment [EOT], and 30 days after last study drug; Expansion part: Predose on Day 1 of Cycles 1 to 5, then every fourth cycle until PD) | The ADA assessment was performed according to a tiered approach. First samples were screened for an ADA response; positively screened samples were analyzed in a confirmation method. Subsequently confirmed positive samples were analyzed for titre and the presence of neutralizing antibodies. Number of participants with ADA confirmed positive to enapotamab vedotin is reported. |
| Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | Day 1 through 44.5 months (maximum observed duration) | Radiological evaluation based on RECIST v1.1 was performed by the investigator using computed tomography (CT) scans/ magnetic resonance imaging (MRI) scans/ positron emission tomography (PET) scans. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to \< 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD. |
| Number of Participants With Best Cancer Antigen 125 (CA-125) Response | From Screening (within 2 weeks before starting of the study treatment) through Day 1130 (maximum observed duration) | The best CA-125 response was evaluated in participants with ovarian cancer. A CA-125 partial response was defined as at least a 50% reduction in CA-125 levels in blood from a pretreatment sample. Participants who had a CA-125 partial response and had CA-125 level falls to within the reference range (0-35 units/mL) were classified as CA-125 complete responders. The response was confirmed and maintained for at least 28 days. The best overall response (CA-125 partial response and CA-125 complete response) is reported. |
| Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part | Day 1 through 44.5 months (maximum observed duration) | The DoR was defined as the number of months from the first documentation of objective tumor response (CR or PR) to the date of first progressive disease (PD) or death. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to \< 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD. The PD was defined as at least 20% increase in the sum of LD of target lesions taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new target and non-target lesions and/or unequivocal progression of existing non-target lesions. |
| Progression Free Survival (PFS) as Assessed by Investigator | Day 1 through 44.5 months (maximum observed duration) | The PFS was defined as the number of months from the date of first study drug administration to first PD or death. The PD was defined as at least 20% increase in the sum of longest diameters of target lesions taking as reference the smallest sum of the longest diameters recorded since the treatment started or the appearance of one or more new lesions. The PFS was estimated using Kaplan-Meier method. |
| Overall Survival (OS) | Day 1 through 44.5 months (maximum observed duration) | Overall survival was defined as the number of months from date of first study drug administration to death. The OS was estimated using Kaplan-Meier method. |
| Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part | Baseline (Study Days -21 to 1) and EOT visit (Day 1100) | Change in AXL expression (total humor H-score in membrane or cytoplasm) from Baseline to EOT visit for the expansion part is reported. The H-score captures both the intensity and proportion of AXL positive tumor cells and was defined by the formula: H-score = (1 × % 1+ tumor cells) + (2 × % 2+ tumor cells) + (3 × % 3+ tumor cells); where '1+' indicates weak staining intensity, '2+' indicates medium staining intensity, and '3+' indicates strong staining intensity. The H-score values ranges from 0 to 300. Lower H-scores represent lower AXL expression in the tumor sample, while higher scores represent stronger AXL expression in the tumor samples. |
| Tmax of MMAE for Dose-escalation Part | For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3 | The Tmax of MMAE for dose-escalation part is reported. |
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Predose, end of infusion (EOI), and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3 | The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure. |
| Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3 | The AUC0-last of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure. |
| Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3 | The Cmax of conjugated enapotamab vedotin for dose-escalation part is reported. |
| Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3 | The total CL of conjugated enapotamab vedotin in dose-escalation part is reported. |
Countries
Belgium, Denmark, Netherlands, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment. | 1 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment. | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment. | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment. | 3 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment. | 10 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment. | 11 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment. | 3 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment. | 3 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment. | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment. | 6 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment. | 3 |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W Participants with advanced and/or classical metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment. | 22 |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment. | 16 |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment. | 25 |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment. | 25 |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment. | 44 |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment. | 25 |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment. | 55 |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment. | 21 |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment. | 26 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 3 | 1 | 6 | 10 | 1 | 2 | 1 | 5 | 1 | 8 | 9 | 17 | 18 | 30 | 17 | 38 | 14 | 16 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 2 | 3 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 |
| Overall Study | Sponsor decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 2 | 6 | 2 | 3 | 2 | 7 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 1 | 3 | 1 | 2 | 1 | 1 | 1 | 1 | 12 | 6 | 6 | 4 | 5 | 4 | 11 | 4 | 2 |
Baseline characteristics
| Characteristic | Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized >=18 to <65 years | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 9 Participants | 5 Participants | 2 Participants | 1 Participants | 2 Participants | 4 Participants | 3 Participants | 12 Participants | 14 Participants | 13 Participants | 15 Participants | 23 Participants | 16 Participants | 24 Participants | 15 Participants | 17 Participants | 180 Participants |
| Age, Customized >=65 years | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 6 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 10 Participants | 2 Participants | 12 Participants | 10 Participants | 21 Participants | 9 Participants | 31 Participants | 6 Participants | 9 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 10 Participants | 11 Participants | 2 Participants | 3 Participants | 3 Participants | 6 Participants | 3 Participants | 22 Participants | 16 Participants | 24 Participants | 24 Participants | 43 Participants | 23 Participants | 53 Participants | 21 Participants | 25 Participants | 297 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 0 Participants | 2 Participants | 17 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 10 Participants | 10 Participants | 2 Participants | 3 Participants | 2 Participants | 6 Participants | 3 Participants | 18 Participants | 12 Participants | 21 Participants | 24 Participants | 37 Participants | 20 Participants | 50 Participants | 20 Participants | 23 Participants | 269 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 7 Participants | 10 Participants | 3 Participants | 2 Participants | 2 Participants | 6 Participants | 3 Participants | 13 Participants | 8 Participants | 7 Participants | 14 Participants | 17 Participants | 25 Participants | 25 Participants | 11 Participants | 13 Participants | 174 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 9 Participants | 8 Participants | 18 Participants | 11 Participants | 27 Participants | 0 Participants | 30 Participants | 10 Participants | 13 Participants | 132 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 1 / 1 | 3 / 3 | 1 / 3 | 6 / 10 | 10 / 11 | 1 / 3 | 2 / 3 | 1 / 3 | 5 / 6 | 1 / 3 | 8 / 22 | 9 / 16 | 17 / 25 | 18 / 25 | 30 / 44 | 17 / 25 | 38 / 56 | 14 / 22 | 16 / 26 |
| other Total, other adverse events | 1 / 1 | 1 / 1 | 3 / 3 | 3 / 3 | 10 / 10 | 11 / 11 | 3 / 3 | 3 / 3 | 3 / 3 | 6 / 6 | 3 / 3 | 22 / 22 | 16 / 16 | 24 / 25 | 25 / 25 | 44 / 44 | 25 / 25 | 56 / 56 | 20 / 20 | 23 / 26 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 3 | 2 / 3 | 7 / 10 | 6 / 11 | 2 / 3 | 1 / 3 | 0 / 3 | 2 / 6 | 3 / 3 | 15 / 22 | 5 / 16 | 16 / 25 | 10 / 25 | 16 / 44 | 12 / 25 | 33 / 56 | 7 / 20 | 14 / 26 |
Outcome results
Primary
Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part
The DLTs were defined as Grade (G) 4 neutropenia or G4 thrombocytopenia for a minimal duration of 7 days, G3 and G4 febrile neutropenia, \>=G3 hemorrhage associated with \>=G3 thrombocytopenia, G4 anemia; Stevens Johnson syndrome, toxic epidermal necrolysis, \>=G3 cutaneous vasculitis; G3 neuropathy (not improved to G1 within 3 weeks following pausing of dosing) and G4 neuropathy; G3 infusion-related reactions (IRR) that did not resolve to G1 or baseline within 24 hours; G4 IRR or G4 anaphylaxis events; \>= G3 diarrhoea and/or vomiting persisting \>48 hours or G3 nausea lasting 7 days (both despite optimal medical management); or any \>=G3 related non-hematological AEs, which occurred during the Cycle 1 and regarded as medically important as assessed by the Data Monitoring Committee (excluding Grade 3 fatigue or non-hematological laboratory abnormalities as specified in protocol).
Time frame: From Day 1 to Day 21 of first cycle for 1Q3W dosing regimen and from Day 1 to Day 28 of first cycle for 3Q4W dosing regimen
Population: Dose-determining set included all participants from the Safety Set (participants who received at least 1 dose of enapotamab vedotin, had at least one valid post-baseline safety assessment, and were classified according to first dose received) who either met the minimum exposure criterion and completed the DLT observation period, or who experienced a DLT during Cycle 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part | 2 Participants |
Primary
Number of Participants With Grade 3 or 4 Laboratory Results
Number of participants with laboratory measurements graded as Grade 3 or 4 by NCI-CTCAE v 4.03 is reported.
Time frame: Day 1 through Day 1130 (maximum observed duration)
Population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 4 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 4 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 1 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 5 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 1 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 1 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 1 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 5 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 1 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 5 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 1 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 1 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 2 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 1 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 1 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 1 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 1 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 1 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 2 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 3 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 1 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 1 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 2 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 1 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 1 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 5 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 1 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 2 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 4 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 7 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 1 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 1 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 7 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 1 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 4 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 1 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 3 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 1 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 3 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 0 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 1 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 7 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 1 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 2 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 1 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 1 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 1 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 1 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 3 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 1 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 1 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 3 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 1 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 9 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 1 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 2 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 8 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 1 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 2 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 3 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 3 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 1 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 4 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 1 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 1 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 1 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 1 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 1 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 5 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 8 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 4 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 7 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 4 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 1 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 1 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 1 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 8 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 1 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 9 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 1 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 1 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 3 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Calcium | 1 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Activated partial thromboplastin time | 0 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Hemoglobin | 0 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Gamma-glutamyl transferase | 3 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Aspartate aminotransferase | 0 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lipase | 1 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Magnesium | 2 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Albumin | 0 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Lymphocytes | 4 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Potassium | 1 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Cholesterol | 0 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Leukocytes | 1 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alkaline Phosphatase | 1 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Prothrombin Intl. Normalized Ratio | 1 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Amylase | 1 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Neutrophils | 2 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Alanine aminotransferase | 1 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Sodium | 3 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Triglycerides | 0 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Grade 3 or 4 Laboratory Results | Bilirubin | 0 Participants |
Primary
Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Number of participants with TEAEs of \>= Grade 3 as assessed by NCI-CTCAE v4.03 is reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. If a participant reported multiple severity grades for an AE, only the maximum grade was used.
Time frame: Day 1 through Day 1130 (maximum observed duration)
Population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 7 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 9 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 3 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 15 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 6 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 18 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 16 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 21 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 15 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 40 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 14 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 13 Participants |
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly/birth defect, is medically important, results in death, or is life-threatening. In this trial, a TEAE was defined as an AE occurring or worsening between the first dose of enapotamab vedotin and 30 days after the last dose received.
Time frame: Day 1 through Day 1130 (maximum observed duration)
Population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 7 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 10 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 6 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 11 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 6 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 3 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 15 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 22 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 16 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 5 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 25 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 16 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 25 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 10 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 44 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 16 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 25 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 12 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 56 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 33 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 7 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 20 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAE | 14 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAE | 26 Participants |
Primary
Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin
Number of participants with treatment-emergent infusion-related AEs and TEAEs related to enapotamab vedotin is reported.
Time frame: Day 1 through Day 1130 (maximum observed duration)
Population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 10 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 10 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 6 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 3 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 21 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 15 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 1 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 24 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 2 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 24 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 2 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 38 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 23 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 52 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 16 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 1 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | TEAEs related to enapotamab vedotin | 20 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin | Treatment emergent infusion-related AEs | 0 Participants |
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Time frame: Predose, end of infusion (EOI), and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Population: Pharmacokinetic (PK) analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 6.143 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 5.780 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 13.233 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 10.892 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 18.664 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 18.353 day*ug/mL | Geometric Coefficient of Variation 8.6 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 40.921 day*ug/mL | Geometric Coefficient of Variation 27.7 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 39.589 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 64.140 day*ug/mL | Geometric Coefficient of Variation 13.2 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 56.842 day*ug/mL | Geometric Coefficient of Variation 23.8 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 61.161 day*ug/mL | Geometric Coefficient of Variation 10.7 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 67.998 day*ug/mL | Geometric Coefficient of Variation 32.2 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 76.264 day*ug/mL | Geometric Coefficient of Variation 31.7 |
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
The AUC0-last of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Time frame: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 5.509 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 5.306 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 10.369 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 9.157 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 15.047 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 16.004 day*ug/mL | Geometric Coefficient of Variation 18.5 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 36.526 day*ug/mL | Geometric Coefficient of Variation 29.7 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 36.333 day*ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 58.410 day*ug/mL | Geometric Coefficient of Variation 11.6 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 51.541 day*ug/mL | Geometric Coefficient of Variation 21.4 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 57.759 day*ug/mL | Geometric Coefficient of Variation 11.9 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 62.563 day*ug/mL | Geometric Coefficient of Variation 29.7 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 71.196 day*ug/mL | Geometric Coefficient of Variation 32.5 |
Secondary
AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part
The AUC0-inf of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Time frame: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 3832.48 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 3248.46 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 6144.11 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 7452.05 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 13673.7 day*pg/mL | Geometric Coefficient of Variation 110.4 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 4338.20 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 26549.1 day*pg/mL | Geometric Coefficient of Variation 82.9 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 47093.9 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 33494.5 day*pg/mL | Geometric Coefficient of Variation 47.1 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 30512.0 day*pg/mL | Geometric Coefficient of Variation 47.8 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 50459.6 day*pg/mL | Geometric Coefficient of Variation 117 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 34188.6 day*pg/mL | Geometric Coefficient of Variation 46.6 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 48626.4 day*pg/mL | Geometric Coefficient of Variation 95.5 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part | Cycle 3 Day 1 | 16754.5 day*pg/mL | — |
Secondary
AUC0-last of MMAE for 1Q3W Dose-escalation Part
The AUC0-last of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Time frame: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 3364.64 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle3 Day 1 | 2642.23 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 5980.86 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle3 Day 1 | 7263.16 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 13194.4 day*pg/mL | Geometric Coefficient of Variation 110.4 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle3 Day 1 | 4156.66 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 25549.3 day*pg/mL | Geometric Coefficient of Variation 80.8 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle3 Day 1 | 44553.3 day*pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 31854.7 day*pg/mL | Geometric Coefficient of Variation 46.4 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle3 Day 1 | 28890.0 day*pg/mL | Geometric Coefficient of Variation 47.4 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 34659.4 day*pg/mL | Geometric Coefficient of Variation 81.2 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle3 Day 1 | 31429.9 day*pg/mL | Geometric Coefficient of Variation 43.2 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle 1 Day 1 | 38963.5 day*pg/mL | Geometric Coefficient of Variation 65.4 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | AUC0-last of MMAE for 1Q3W Dose-escalation Part | Cycle3 Day 1 | 16354.3 day*pg/mL | — |
Secondary
Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part
Change in AXL expression (total humor H-score in membrane or cytoplasm) from Baseline to EOT visit for the expansion part is reported. The H-score captures both the intensity and proportion of AXL positive tumor cells and was defined by the formula: H-score = (1 × % 1+ tumor cells) + (2 × % 2+ tumor cells) + (3 × % 3+ tumor cells); where '1+' indicates weak staining intensity, '2+' indicates medium staining intensity, and '3+' indicates strong staining intensity. The H-score values ranges from 0 to 300. Lower H-scores represent lower AXL expression in the tumor sample, while higher scores represent stronger AXL expression in the tumor samples.
Time frame: Baseline (Study Days -21 to 1) and EOT visit (Day 1100)
Population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received in the expansion part. Participants who had tumor H-scores in membrane or cytoplasm assessed at Baseline and at the end of treatment visit were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part | -8.0 Score on a scale |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part | -1.0 Score on a scale |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part | -30.0 Score on a scale |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part | 35.0 Score on a scale |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part | -14.0 Score on a scale |
Secondary
Cmax of MMAE for Dose-escalation Part
The Cmax of MMAE for dose-escalation part is reported.
Time frame: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 700.000 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 631.000 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 1200.000 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 947.000 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 628.000 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 1874.13 pg/mL | Geometric Coefficient of Variation 5 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 6500.00 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 4036.47 pg/mL | Geometric Coefficient of Variation 81.8 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 3964.40 pg/mL | Geometric Coefficient of Variation 49.4 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 4265.60 pg/mL | Geometric Coefficient of Variation 46.1 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 5154.58 pg/mL | Geometric Coefficient of Variation 61.9 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 4127.31 pg/mL | Geometric Coefficient of Variation 39.3 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 5617.89 pg/mL | Geometric Coefficient of Variation 34.7 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 2180.00 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 161.140 pg/mL | Geometric Coefficient of Variation 75 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 8 | 738.227 pg/mL | Geometric Coefficient of Variation 28.2 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 1715.54 pg/mL | Geometric Coefficient of Variation 42.8 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 442.000 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 2525.75 pg/mL | Geometric Coefficient of Variation 54.7 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 175.315 pg/mL | Geometric Coefficient of Variation 159.4 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 8 | 1060.00 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 15 | 2960.00 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 8 | 766.467 pg/mL | Geometric Coefficient of Variation 91.4 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 15 | 5190.00 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 8 | 1982.67 pg/mL | Geometric Coefficient of Variation 58.1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 303.977 pg/mL | Geometric Coefficient of Variation 45.3 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 558.000 pg/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 4379.50 pg/mL | Geometric Coefficient of Variation 58.2 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 8 | 1553.93 pg/mL | Geometric Coefficient of Variation 86.2 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 244.623 pg/mL | Geometric Coefficient of Variation 48.9 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Cmax of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 3720.00 pg/mL | — |
Secondary
Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part
The DoR was defined as the number of months from the first documentation of objective tumor response (CR or PR) to the date of first progressive disease (PD) or death. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to \< 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD. The PD was defined as at least 20% increase in the sum of LD of target lesions taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new target and non-target lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Day 1 through 44.5 months (maximum observed duration)
Population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part | 4.2 Months |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part | 4.1 Months |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part | 4.9 Months |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part | 3.0 Months |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part | NA Months |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part | 3.0 Months |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part | 4.9 Months |
Secondary
Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The t1/2 of conjugated enapotamab vedotin for dose-escalation part is reported.
Time frame: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 0.87 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 0.78 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 1.49 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 1.07 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 1.130 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 1.362 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 1.68 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 1.384 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 2.004 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 2.117 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 2.035 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 1.810 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 2.153 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 1.097 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 1.398 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 15 | 1.51 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 15 | 1.44 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 1.423 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 2.05 Day |
Secondary
Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The Cmax of conjugated enapotamab vedotin for dose-escalation part is reported.
Time frame: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 6.870 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 7.250 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 12.600 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 11.000 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 16.200 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 16.615 ug/mL | Geometric Coefficient of Variation 16.7 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 33.005 ug/mL | Geometric Coefficient of Variation 9.4 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 32.400 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 35.890 ug/mL | Geometric Coefficient of Variation 17.9 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 39.647 ug/mL | Geometric Coefficient of Variation 11.4 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 38.928 ug/mL | Geometric Coefficient of Variation 9 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 43.377 ug/mL | Geometric Coefficient of Variation 25.6 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 48.548 ug/mL | Geometric Coefficient of Variation 33 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 13.172 ug/mL | Geometric Coefficient of Variation 8 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 10.127 ug/mL | Geometric Coefficient of Variation 40.2 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 8 | 14.201 ug/mL | Geometric Coefficient of Variation 11.9 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 8 | 21.200 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 15 | 24.100 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 14.307 ug/mL | Geometric Coefficient of Variation 31.6 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 22.400 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 16.166 ug/mL | Geometric Coefficient of Variation 37.2 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 8 | 16.765 ug/mL | Geometric Coefficient of Variation 36.3 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 15 | 22.800 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 16.991 ug/mL | Geometric Coefficient of Variation 7.8 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 8 | 18.698 ug/mL | Geometric Coefficient of Variation 8.1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 18.040 ug/mL | Geometric Coefficient of Variation 12 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 21.800 ug/mL | — |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 17.928 ug/mL | Geometric Coefficient of Variation 22 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 8 | 18.958 ug/mL | Geometric Coefficient of Variation 19.5 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 18.500 ug/mL | — |
Secondary
Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin
The ADA assessment was performed according to a tiered approach. First samples were screened for an ADA response; positively screened samples were analyzed in a confirmation method. Subsequently confirmed positive samples were analyzed for titre and the presence of neutralizing antibodies. Number of participants with ADA confirmed positive to enapotamab vedotin is reported.
Time frame: Day 1 through Day 1130 (Dose-escalation part: Predose of Day 1 of Cycles 1 to 12, end of treatment [EOT], and 30 days after last study drug; Expansion part: Predose on Day 1 of Cycles 1 to 5, then every fourth cycle until PD)
Population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 5 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 2 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 0 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 4 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 1 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 3 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 0 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 7 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 5 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 0 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin | 0 Participants |
Secondary
Number of Participants With Best Cancer Antigen 125 (CA-125) Response
The best CA-125 response was evaluated in participants with ovarian cancer. A CA-125 partial response was defined as at least a 50% reduction in CA-125 levels in blood from a pretreatment sample. Participants who had a CA-125 partial response and had CA-125 level falls to within the reference range (0-35 units/mL) were classified as CA-125 complete responders. The response was confirmed and maintained for at least 28 days. The best overall response (CA-125 partial response and CA-125 complete response) is reported.
Time frame: From Screening (within 2 weeks before starting of the study treatment) through Day 1130 (maximum observed duration)
Population: Participants from the full analysis set with ovarian cancer who had an initial CA-125 level of at least twice the upper limit of the reference range within 2 weeks before starting the study treatment were evaluated for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 partial response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 complete response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 partial response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 complete response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 partial response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 complete response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 partial response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 complete response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 partial response | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 complete response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 complete response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 partial response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 complete response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 partial response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 partial response | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 complete response | 0 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 partial response | 2 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Best Cancer Antigen 125 (CA-125) Response | CA-125 complete response | 0 Participants |
Secondary
Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator
Radiological evaluation based on RECIST v1.1 was performed by the investigator using computed tomography (CT) scans/ magnetic resonance imaging (MRI) scans/ positron emission tomography (PET) scans. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to \< 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD.
Time frame: Day 1 through 44.5 months (maximum observed duration)
Population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 1 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 0 Participants |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 0 Participants |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 1 Participants |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 2 Participants |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 3 Participants |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 0 Participants |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 4 Participants |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 2 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 5 Participants |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 1 Participants |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator | 3 Participants |
Secondary
Overall Survival (OS)
Overall survival was defined as the number of months from date of first study drug administration to death. The OS was estimated using Kaplan-Meier method.
Time frame: Day 1 through 44.5 months (maximum observed duration)
Population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Overall Survival (OS) | NA Months |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Overall Survival (OS) | 4.3 Months |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Overall Survival (OS) | 6.4 Months |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Overall Survival (OS) | NA Months |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Overall Survival (OS) | 14.5 Months |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Overall Survival (OS) | 7.6 Months |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Overall Survival (OS) | 44.5 Months |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Overall Survival (OS) | 6.7 Months |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Overall Survival (OS) | 14.3 Months |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Overall Survival (OS) | 7.7 Months |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Overall Survival (OS) | 21.7 Months |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Overall Survival (OS) | 16.5 Months |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Overall Survival (OS) | 8.6 Months |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Overall Survival (OS) | 9.2 Months |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Overall Survival (OS) | 17.1 Months |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Overall Survival (OS) | 7.0 Months |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Overall Survival (OS) | 8.4 Months |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Overall Survival (OS) | 11.3 Months |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Overall Survival (OS) | 8.7 Months |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Overall Survival (OS) | 8.0 Months |
Secondary
Progression Free Survival (PFS) as Assessed by Investigator
The PFS was defined as the number of months from the date of first study drug administration to first PD or death. The PD was defined as at least 20% increase in the sum of longest diameters of target lesions taking as reference the smallest sum of the longest diameters recorded since the treatment started or the appearance of one or more new lesions. The PFS was estimated using Kaplan-Meier method.
Time frame: Day 1 through 44.5 months (maximum observed duration)
Population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 6.7 Months |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 3.5 Months |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 1.3 Months |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 5.3 Months |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 2.8 Months |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 2.6 Months |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | NA Months |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Progression Free Survival (PFS) as Assessed by Investigator | 1.6 Months |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Progression Free Survival (PFS) as Assessed by Investigator | 1.6 Months |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Progression Free Survival (PFS) as Assessed by Investigator | 4.3 Months |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Progression Free Survival (PFS) as Assessed by Investigator | 0.8 Months |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 2.6 Months |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 2.6 Months |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 2.8 Months |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 2.6 Months |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Progression Free Survival (PFS) as Assessed by Investigator | 1.9 Months |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 1.6 Months |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 2.2 Months |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | Progression Free Survival (PFS) as Assessed by Investigator | 2.6 Months |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Progression Free Survival (PFS) as Assessed by Investigator | 2.0 Months |
Secondary
t1/2 of MMAE for Dose-escalation Part
The t1/2 of MMAE for dose-escalation part is reported.
Time frame: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 1.94 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.19 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.35 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 2.32 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 2.71 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.470 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 2.52 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.620 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.420 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 2.746 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 3.364 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 3.128 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.835 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | t1/2 of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 1.98 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | t1/2 of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 3.976 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | t1/2 of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 3.115 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | t1/2 of MMAE for Dose-escalation Part | Cycle 3 Day 15 | 2.330 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | t1/2 of MMAE for Dose-escalation Part | Cycle 3 Day 15 | 3.37 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | t1/2 of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 4.739 Day |
Secondary
Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The Tmax of conjugated enapotamab vedotin for dose-escalation part is reported.
Time frame: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 0.06 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 0.04 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 0.03 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 0.03 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 0.04 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 0.036 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 0.030 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 0.033 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 0.032 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 0.036 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 0.042 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 0.032 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 0.03 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 14.010 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 14.058 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 15 | 14.02 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 15 | 13.98 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 14.083 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 13.98 Day |
Secondary
Tmax of MMAE for Dose-escalation Part
The Tmax of MMAE for dose-escalation part is reported.
Time frame: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.95 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 2.83 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 2.87 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 3.00 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 0.94 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.938 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.764 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 2.83 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.852 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 2.830 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 2.727 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.866 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 3 Day 1 | 3.02 Day |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 1 | 2.942 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 15.950 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 15.982 Day |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Tmax of MMAE for Dose-escalation Part | Cycle 3 Day 15 | 14.93 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Tmax of MMAE for Dose-escalation Part | Cycle 3 Day 15 | 15.890 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 15.911 Day |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Tmax of MMAE for Dose-escalation Part | Cycle 1 Day 15 | 20.820 Day |
Secondary
Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part
The total CL of conjugated enapotamab vedotin in dose-escalation part is reported.
Time frame: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 1 | 4.053 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 3 day 1 | 4.360 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 1 | 3.446 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 3 day 1 | 4.187 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 3 day 1 | 3.000 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 1 | 3.538 L/day | Geometric Coefficient of Variation 21.8 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 3 day 1 | 2.160 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 1 | 2.307 L/day | Geometric Coefficient of Variation 28.3 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 1 | 2.202 L/day | Geometric Coefficient of Variation 22.2 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 3 day 1 | 2.285 L/day | Geometric Coefficient of Variation 27.1 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 3 day 1 | 2.539 L/day | Geometric Coefficient of Variation 14.7 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 1 | 2.205 L/day | Geometric Coefficient of Variation 25.4 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 1 | 1.783 L/day | Geometric Coefficient of Variation 24.3 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 15 | 3.679 L/day | Geometric Coefficient of Variation 9.4 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 15 | 3.084 L/day | Geometric Coefficient of Variation 93.8 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 3 Day 15 | 2.281 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 3 Day 15 | 3.412 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 15 | 3.402 L/day | Geometric Coefficient of Variation 31.3 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part | Cycle 1 Day 15 | 2.629 L/day | — |
Secondary
Total CL of MMAE in Dose-escalation Part
The total CL of MMAE in dose-escalation part is reported.
Time frame: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 3 day 1 | 7757.51 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 1 Day 1 | 6497.09 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 1 Day 1 | 7421.74 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 3 day 1 | 6119.12 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 3 day 1 | 12908.6 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 1 Day 1 | 4748.64 L/day | Geometric Coefficient of Variation 87.2 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 3 day 1 | 1815.52 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 1 Day 1 | 3555.78 L/day | Geometric Coefficient of Variation 90.6 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 1 Day 1 | 4216.71 L/day | Geometric Coefficient of Variation 42 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 3 day 1 | 4256.44 L/day | Geometric Coefficient of Variation 50.1 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 3 day 1 | 4542.22 L/day | Geometric Coefficient of Variation 42.8 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 1 Day 1 | 2971.09 L/day | Geometric Coefficient of Variation 107.2 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 1 Day 1 | 2813.05 L/day | Geometric Coefficient of Variation 35.9 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Total CL of MMAE in Dose-escalation Part | Cycle 3 day 1 | 5849.18 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Total CL of MMAE in Dose-escalation Part | Cycle 1 Day 15 | 4819.44 L/day | Geometric Coefficient of Variation 25.8 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Total CL of MMAE in Dose-escalation Part | Cycle 1 Day 15 | 4666.23 L/day | Geometric Coefficient of Variation 35.5 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Total CL of MMAE in Dose-escalation Part | Cycle 3 Day 15 | 3899.39 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Total CL of MMAE in Dose-escalation Part | Cycle 3 Day 15 | 2507.90 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Total CL of MMAE in Dose-escalation Part | Cycle 1 Day 15 | 2847.55 L/day | Geometric Coefficient of Variation 46.7 |
Secondary
Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The Vss of conjugated enapotamab vedotin for dose-escalation part is reported.
Time frame: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 4.755 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 4.909 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 6.288 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 6.544 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 4.870 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 5.873 L/day | Geometric Coefficient of Variation 9.8 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 4.534 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 4.208 L/day | Geometric Coefficient of Variation 12.5 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 6.072 L/day | Geometric Coefficient of Variation 24.2 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 6.028 L/day | Geometric Coefficient of Variation 18.4 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 5.489 L/day | Geometric Coefficient of Variation 24.2 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 1 | 6.656 L/day | Geometric Coefficient of Variation 22 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 1 | 5.038 L/day | Geometric Coefficient of Variation 27.3 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 57.736 L/day | Geometric Coefficient of Variation 10 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 48.001 L/day | Geometric Coefficient of Variation 91.1 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 15 | 36.476 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 53.436 L/day | Geometric Coefficient of Variation 28 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 3 Day 15 | 53.085 L/day | — |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part | Cycle 1 Day 15 | 42.708 L/day | — |