Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04082364 | Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer | PHASE2 | COMPLETED | 82 | — | — | Sep 30, 2019 | Mar 25, 2025 | Jun 8, 2025 | 73 | United States, China +7 |
| NCT02689284 | Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer | PHASE1 | COMPLETED | 95 | — | — | Jan 1, 2016 | Jan 1, 2021 | Mar 17, 2025 | 28 | United States, Canada +3 |
Evaluation of adverse events and serious adverse events (Cohort A)
Percent of non MSI-H participants with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A ) based on investigator assessment. CR is defined as the disappearance of all target and non-target lesions with no new lesions appearing PR is defined as \>= to a 30% decrease in the sum of the longest dimensions of target lesions, non-progression of non- target lesions, with no new lesions appearing. CR + PR = ORR
Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab when administered in combination with pembrolizumab
The number of patients that experience either an AE or a SAE during the study participation
Investigate the preliminary anti-tumor activity as measured by response to treatment of margetuximab when administered in combination with pembrolizumab, using conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Investigate the preliminary anti-tumor activity, as measured by objective response rate (ORR) of margetuximab when administered in combination with pembrolizumab, using immune-related response criteria (irRC).
Duration of response is calculated at the time from CR or PR to relapse or cancer progression.
| Arm | Type | Description |
|---|---|---|
| Chemotherapy-free arm | EXPERIMENTAL | margetuximab plus retifanlimab |
| Margetuximab, retifanlimab, and chemotherapy arm | EXPERIMENTAL | margetuximab plus retifanlimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
| Margetuximab, tebotelimab and chemotherapy arm | EXPERIMENTAL | margetuximab plus tebotelimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
| Margetuximab and chemotherapy arm | EXPERIMENTAL | margetuximab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
| Trastuzumab and chemotherapy arm | ACTIVE_COMPARATOR | Trastuzumab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
| Cohort 1: Margetuximab 10 mg/kg plus pembrolizumab 200 mg | EXPERIMENTAL | margetuximab administered in combination with pembrolizumab |
| Cohort 2: Margetuximab 15 mg/kg plus pembrolizumab 200 mg | EXPERIMENTAL | margetuximab administered in combination with pembrolizumab |
| Name | Type | Description |
|---|---|---|
| margetuximab | BIOLOGICAL | margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle |
| Retifanlimab | BIOLOGICAL | Retifanlimab: anti-PD-1 checkpoint inhibitor 375 mg IV, Day 1 of each 3-week cycle. |
| Tebotelimab | BIOLOGICAL | Tebotelimab: anti PD-1, anti-LAG3 bispecific DART (R) molecule 600 mg IV, Day 1 of each 3-week cycle. |
| Trastuzumab | BIOLOGICAL | Anti-HER2 monoclonal antibody 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle |
| Chemotherapy | OTHER | Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 Chemotherapy XELOX chemotherapy Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion mFOLFOX6 chemotherapy: Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion. |
| Margetuximab 10 mg/kg | BIOLOGICAL | Margetuximab treatment is administered intravenously (IV) once every 21-day cycle |
| Margetuximab 15 mg | BIOLOGICAL | Margetuximab treatment is administered IV once every 21-day cycle |
| Pembrolizumab | BIOLOGICAL | Pembrolizumab treatment is administered IV once every 21-day cycle |
Key Inclusion Criteria: * Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma 1. Prior systemic perioperative treatment is allowed; however the participants must have had a disease-free interval of at least 6 month...