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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05111626 | Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer. | PHASE3 | ACTIVE NOT_RECRUITING | 515 | — | — | Mar 14, 2022 | Jan 29, 2027 | Dec 15, 2025 | 348 | United States, Argentina +27 |
| NCT05052801 | Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression | PHASE3 | COMPLETED | 547 | — | — | Mar 7, 2022 | Apr 26, 2026 | May 27, 2026 | 300 | United States, Argentina +35 |
| NCT03694522 | A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer | PHASE2 | COMPLETED | 155 | — | — | Sep 14, 2018 | May 13, 2022 | Feb 28, 2024 | 189 | United States, Australia +16 |
| NCT05322577 | A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer. | PHASE1 | ACTIVE NOT_RECRUITING | 72 | — | — | May 17, 2022 | Aug 12, 2026 | Dec 5, 2025 | 42 | United States, Japan +3 |
Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
PFS was defined as time from randomization until the date of radiographic disease progression based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death from any cause, whichever came first. PFS was analyzed using Kaplan-Meier methods. Participants with no progression or death, or who started new anticancer therapy before documented progression or death without documented progression, or who had ≥ 2 consecutive missing tumor assessments before documented progression or death without documented progression were censored on the date of last adequate tumor assessment. Participants with no baseline tumor assessment, were censored at the date of randomization. The primary efficacy analysis was pre-specified to be conducted after at least 84 PFS events were observed.
| Arm | Type | Description |
|---|---|---|
| Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab | EXPERIMENTAL | Participants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK). |
| Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab | EXPERIMENTAL | Participants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle. Or participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle. |
| Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab | PLACEBO_COMPARATOR | Participants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle. Or participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle. |
| Bemarituzumab with mFOLFOX6 | EXPERIMENTAL | - |
| Placebo with mFOLFOX6 | ACTIVE_COMPARATOR | - |
| Bemarituzumab + mFOLFOX6 | EXPERIMENTAL | Participants received 15 mg/kg bemarituzumab administered every 2 weeks (Q2W) with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death. |
| Placebo + mFOLFOX6 | PLACEBO_COMPARATOR | Participants received placebo for bemarituzumab administered every 2 weeks with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death. |
| Part 1 Cohort A: Bemarituzumab with CAPOX | EXPERIMENTAL | - |
| Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab | EXPERIMENTAL | - |
| Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab | EXPERIMENTAL | - |
| Part 2: Bemarituzumab with SOX and Nivolumab. | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bemarituzumab | DRUG | Bemarituzumab will be administered as intravenous (IV) infusion. |
| Nivolumab | DRUG | Nivolumab will be administered as IV infusion. |
| Chemotherapy | DRUG | mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion. OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally. |
| Placebo | OTHER | Placebo will be administered as IV infusion. |
| mFOLFOX6 | DRUG | mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion. |
| Modified FOLFOX6 | DRUG | mFOLFOX6 regimen consists of the following: * Oxaliplatin 85 mg/m² IV infusion over 120 minutes * Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable * 5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours |
| CAPOX | DRUG | CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets. |
| SOX | DRUG | SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally. |
Inclusion Criteria Part 1 and Part 2: * Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Measurable dise...