Breast Cancer, Colorectal Cancer, Esophagogastric Cancer, Non-small Cell Lung Cancer, Pancreatic Cancer
Conditions
Keywords
Solid Tumor
Brief summary
The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy. The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part. Part A is a sequential dose escalation to determine the maximum tolerated dose of andecaliximab in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive andecaliximab only. Part B is a dose expansion to obtain additional safety and tolerability data for andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive andecaliximab in combination with standard-of-care chemotherapy.
Interventions
DRUGAndecaliximab
Administered intravenous infusion
DRUGGemcitabine
Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
DRUGNab-paclitaxel
Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
DRUGCarboplatin
Administered intravenously on Day 1 of each 21-day treatment cycle
DRUGPemetrexed
Administered intravenously on Day 1 of each 21-day treatment cycle
DRUGLeucovorin
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
DRUGOxaliplatin
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
DRUG5-FU
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
DRUGBevacizumab
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
DRUGIrinotecan
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
DRUGPaclitaxel
Administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle (Breast cancer) or on Day 1 of each 21-day treatment cycle (NSCLC)
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Part A: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of standard therapy or for which no standard therapy is available * Part B: Pancreatic Adenocarcinoma * Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma * Part B: NSCLC * Stage IIIB with malignant pleural effusion/pleural seeding or stage IV histologically confirmed NSCLC * Absence of known epidermal growth factor receptor (EGFR) mutation * Absence of known translocation or inversion events involving the ALK gene locus (resulting in EML4-ALK fusion) * Part B: Esophagogastric Adenocarcinoma: * Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapsed gastric adenocarcinoma * Human epidermal growth factor receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion) * Part B: First-Line Colorectal Cancer * Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum * Radiographically measureable disease * No prior cytotoxic chemotherapy to treat their metastatic disease * Part B: Second-Line Colorectal Cancer * Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum * Radiographically measureable disease * Received first-line combination therapy containing oxaliplatin and fluoropyrimidine with or without bevacizumab for metastatic disease with documented evidence of disease progression during or after treatment completion * Part B: Breast Cancer * Histologically or cytologically confirmed metastatic breast cancer * Radiographically measureable disease * Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed * Treatment with weekly single-agent paclitaxel is appropriate in the opinion of the treating physician * HER-2 negative tumor (primary tumor or metastatic lesion) * Adequate organ function Key
Exclusion criteria
* Pregnant or lactating * Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids * Myocardial infarction, symptomatic congestive heart failure, unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months * Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days | — |
| Percentage of Participants Experiencing Laboratory Abnormalities | Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States. The first participant was screened on 29 March 2013. The last study visit occurred on 23 April 2019.
Pre-assignment details
280 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Part A: ADX 200 mg Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 4 |
| Part A: ADX 600 mg Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 3 |
| Part A: ADX 1800 mg Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 6 |
| Part B: PAC, ADX 800 mg Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 36 |
| Part B: LAC, ADX 1200 mg Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 10 |
| Part B: LSC, ADX 1200 mg Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 10 |
| Part B: EGC, ADX 800 mg Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 40 |
| Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 45 |
| Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 11 |
| Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 44 |
| Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 8 |
| Part B: BRCA, ADX 800 mg Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. | 15 |
| Total | 232 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 0 | 3 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 5 | 1 | 1 | 0 | 0 |
| Overall Study | Enrolled but Never Treated | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Investigator's Discretion | 0 | 0 | 0 | 7 | 2 | 1 | 7 | 10 | 6 | 7 | 1 | 0 |
| Overall Study | Non-Compliance with Study Drug | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Progressive Disease | 4 | 3 | 6 | 22 | 5 | 8 | 23 | 24 | 3 | 29 | 6 | 11 |
| Overall Study | Specified Criteria for Withdrawal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Unknown Reason | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrew Consent | 0 | 0 | 0 | 6 | 1 | 0 | 8 | 3 | 1 | 5 | 0 | 1 |
Baseline characteristics
| Characteristic | Part A: ADX 200 mg | Part A: ADX 600 mg | Part A: ADX 1800 mg | Part B: PAC, ADX 800 mg | Part B: LAC, ADX 1200 mg | Part B: LSC, ADX 1200 mg | Part B: EGC, ADX 800 mg | Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg | Part B: BRCA, ADX 800 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized Age < 65 years | 2 Participants | 0 Participants | 4 Participants | 15 Participants | 2 Participants | 4 Participants | 25 Participants | 26 Participants | 8 Participants | 33 Participants | 4 Participants | 10 Participants | 133 Participants |
| Age, Customized Age ≥ 65 years | 2 Participants | 3 Participants | 2 Participants | 21 Participants | 8 Participants | 6 Participants | 15 Participants | 19 Participants | 3 Participants | 11 Participants | 4 Participants | 5 Participants | 99 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 4 Participants | 4 Participants | 0 Participants | 4 Participants | 0 Participants | 2 Participants | 19 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 4 Participants | 3 Participants | 6 Participants | 32 Participants | 10 Participants | 9 Participants | 30 Participants | 39 Participants | 10 Participants | 39 Participants | 8 Participants | 12 Participants | 202 Participants |
| Race/Ethnicity, Customized Ethnicity Not Permitted | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 11 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 6 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 18 Participants |
| Race/Ethnicity, Customized Race 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 |
| Race/Ethnicity, Customized Race Not Permitted | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 13 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 9 Participants |
| Race/Ethnicity, Customized Race White | 3 Participants | 3 Participants | 5 Participants | 33 Participants | 9 Participants | 5 Participants | 31 Participants | 35 Participants | 8 Participants | 35 Participants | 6 Participants | 12 Participants | 185 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 2 Participants | 10 Participants | 7 Participants | 4 Participants | 9 Participants | 19 Participants | 3 Participants | 25 Participants | 2 Participants | 13 Participants | 95 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 4 Participants | 26 Participants | 3 Participants | 6 Participants | 31 Participants | 26 Participants | 8 Participants | 19 Participants | 6 Participants | 2 Participants | 137 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 4 | 0 / 3 | 1 / 6 | 8 / 36 | 4 / 10 | 3 / 10 | 13 / 40 | 22 / 45 | 5 / 11 | 25 / 44 | 5 / 8 | 8 / 15 |
| other Total, other adverse events | 4 / 4 | 3 / 3 | 5 / 6 | 36 / 36 | 9 / 10 | 10 / 10 | 40 / 40 | 45 / 45 | 11 / 11 | 44 / 44 | 8 / 8 | 15 / 15 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 | 2 / 6 | 19 / 36 | 5 / 10 | 6 / 10 | 19 / 40 | 17 / 45 | 3 / 11 | 13 / 44 | 4 / 8 | 5 / 15 |
Outcome results
Primary
Percentage of Participants Experiencing Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Time frame: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: ADX 200 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 25.0 percentage of participants |
| Part A: ADX 200 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 0.0 percentage of participants |
| Part A: ADX 200 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 100.0 percentage of participants |
| Part A: ADX 600 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 0.0 percentage of participants |
| Part A: ADX 600 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 66.7 percentage of participants |
| Part A: ADX 600 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 33.3 percentage of participants |
| Part A: ADX 1800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 33.3 percentage of participants |
| Part A: ADX 1800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 83.3 percentage of participants |
| Part A: ADX 1800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 33.3 percentage of participants |
| Part B: PAC, ADX 800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 38.9 percentage of participants |
| Part B: PAC, ADX 800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 97.2 percentage of participants |
| Part B: PAC, ADX 800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 88.9 percentage of participants |
| Part B: LAC, ADX 1200 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 90.0 percentage of participants |
| Part B: LAC, ADX 1200 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 60.0 percentage of participants |
| Part B: LAC, ADX 1200 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 10.0 percentage of participants |
| Part B: LSC, ADX 1200 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 10.0 percentage of participants |
| Part B: LSC, ADX 1200 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 80.0 percentage of participants |
| Part B: LSC, ADX 1200 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 70.0 percentage of participants |
| Part B: EGC, ADX 800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 87.5 percentage of participants |
| Part B: EGC, ADX 800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 87.5 percentage of participants |
| Part B: EGC, ADX 800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 35.0 percentage of participants |
| Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 95.6 percentage of participants |
| Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 37.8 percentage of participants |
| Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 84.4 percentage of participants |
| Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 81.8 percentage of participants |
| Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 90.9 percentage of participants |
| Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 36.4 percentage of participants |
| Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 45.5 percentage of participants |
| Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 95.5 percentage of participants |
| Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 86.4 percentage of participants |
| Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 100.0 percentage of participants |
| Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 37.5 percentage of participants |
| Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 87.5 percentage of participants |
| Part B: BRCA, ADX 800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 40.0 percentage of participants |
| Part B: BRCA, ADX 800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 86.7 percentage of participants |
| Part B: BRCA, ADX 800 mg | Percentage of Participants Experiencing Laboratory Abnormalities | Any Laboratory abnormalities: Serum Chemistry | 66.7 percentage of participants |
Primary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
Population: The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: ADX 200 mg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |
| Part A: ADX 600 mg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |
| Part A: ADX 1800 mg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 83.3 percentage of participants |
| Part B: PAC, ADX 800 mg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |
| Part B: LAC, ADX 1200 mg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |
| Part B: LSC, ADX 1200 mg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |
| Part B: EGC, ADX 800 mg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |
| Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |
| Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |
| Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |
| Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |
| Part B: BRCA, ADX 800 mg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 100.0 percentage of participants |