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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06680622 | Bemarituzumab in FGFR2b+ Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy | PHASE2 | ACTIVE NOT_RECRUITING | 126 | — | — | Mar 3, 2025 | Mar 1, 2028 | Jan 7, 2026 | 35 | Germany |
Objective response rate (ORR), defined as proportion of subjects with a complete response (CR) or partial response (PR) acc. to RECIST v1.1, for each cohort (cohort 1 - bemarituzumab plus irinotecan, cohort 2 - bemarituzumab plus paclitaxel and ramucirumab, cohort 3 - bemarituzumab plus trifluridine/tipiracil).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | bemarituzumab plus SOC treatment with irinotecan |
| Cohort 2 | EXPERIMENTAL | bemarituzumab plus SOC treatment with paclitaxel plus ramucirumab |
| Cohort 3 | EXPERIMENTAL | bemarituzumab plus SOC treatment with trifluridine/tipiracil |
| Name | Type | Description |
|---|---|---|
| bemarituzumab, paclitaxel, ramucirumab | DRUG | Cohort 2 will receive bemarituzumab plus SOC treatment with paclitaxel and ramucirumab |
| bemarituzumab, irinotecan | DRUG | Cohort 1 will receive bemarituzumab plus SOC treatment with irinotecan |
| bemarituzumab, trifluridine/tipiracil | DRUG | Cohort 3 will receive bemarituzumab plus SOC treatment with trifluridine/tipiracil |
Inclusion Criteria: 1. Patient provide signed informed consent form. 2. Patient is ≥ 18 years at the time of given informed consent. 3. Patient has been diagnosed with histologically proven advanced or metastatic adenocarcinoma of the stomach or of the gastroesophageal junction, which is not amenab...