Drugs / Bemarituzumab
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06978062 | Feb 2026 → Sep 2028 expected | gastroesophageal cancer | European Organisation for Research and Treatment of Cancer - EORTC | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05267470 | Mar 2022 → May 2024 | non-small cell squamous lung carcinoma | Amgen | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03343301 | Nov 2017 → Jan 2019 | gastric cancer | Five Prime Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05913115 | Jun 2017 → Jun 2018 | gastroesophageal cancer | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02318329 | Nov 2014 → Feb 2019 | bladder transitional cell carcinoma, gastric cancer | Five Prime Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07146919 | Oct 2025 → Oct 2030 | cervical cancer, endometrial carcinoma, ovarian cancer | Centre Leon Berard | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05325866 | Sep 2022 → Jan 2026 | cancer | Amgen | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05322577 | May 2022 → Nov 2025 overdue | gastric cancer, gastroesophageal junction adenocarcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT07470840 | Feb 2027 → Feb 2029 expected | renal cell adenocarcinoma | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06967987 | Jan 2026 | gastroesophageal adenocarcinoma | Institut Cancerologie de l'Ouest | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06680622 | Mar 2025 → Sep 2027 expected | gastroesophageal adenocarcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03694522 | Sep 2018 → Sep 2020 | gastric cancer | Five Prime Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02213289 | Jan 2015 → Feb 2020 | adenocarcinoma | University of Chicago | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05111626 | Mar 2022 → Oct 2025 | gastric cancer, gastroesophageal junction adenocarcinoma | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT05052801 | Mar 2022 → Jun 2025 | gastric cancer, gastroesophageal junction adenocarcinoma | Amgen | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT03801278 | — | urinary bladder cancer | Five Prime Therapeutics, Inc. | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-11-04 | Zai Lab (Shanghai) Co., Ltd. | Results Update on Amgen’s bemarituzumab Phase 1b/3 FORTITUDE-102 Study zailaboratory.com ↗
the Phase 1b/3 FORTITUDE-102 trial evaluating bemarituzumab plus chemotherapy and nivolumab in patients with first-line gastric cancer was stopped for inadequate efficacy |
| 2025-06-30 | Amgen | Results AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR BEMARITUZUMAB IN FIBROBLAST GROWTH FACTOR RECEPTOR 2b (FGFR2b) POSITIVE FIRST-LINE GASTRIC CANCER amgen.com ↗
Amgen ( NASDAQ:AMGN ) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis. |
| 2025-06-30 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis. |
| 2021-09-14 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Breakthrough Therapy Designation Granted for Bemarituzumab (FPA144) in China zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for investigational bemarituzumab (FPA144), for first-line treatment for patients with FGFR2b overexpressing and human epidermal growth factor receptor (HER2)-negative metastatic and locally advanced gastric and GEJ cancers in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin). |
| 2021-06-04 | Amgen | Results Phase 2 Fight Trial Continues To Show Improved Overall Survival With Bemarituzumab Plus Chemotherapy In Patients With FGFR2b+ Gastric And Gastroesophageal Cancers amgen.com ↗
With a median follow-up of 12.5 months, the addition of bemarituzumab to chemotherapy resulted in a median OS of 19.2 months versus 13.5 months for chemotherapy alone in all randomized patients (n=155, HR: 0.6; 95% CI: 0.38, 0.94). |
| 2021-04-19 | Amgen | Regulatory Amgen's Investigational Targeted Treatment Bemarituzumab Granted Breakthrough Therapy Designation amgen.com ↗
the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for investigational bemarituzumab |
| 2020-11-10 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Partner Five Prime Therapeutics Announces Bemarituzumab Plus Chemotherapy Demonstrates Significant Progression-Free and Overall Survival Benefit Compared to Placebo Plus Chemotherapy in Front-Line Advanced Gastric or Gastroesophageal Junction Cancer zailaboratory.com ↗
today announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 2 FIGHT trial. |
All press releases naming this drug 10 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bemarituzumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07470840 ↗ |
| Known as | FPA144 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02318329 ↗ |
| Action | Inhibit | “anti-fibroblast growth factor receptor 2 isoform IIb (FGFR2b) monoclonal antibody bemarituzumab” PMID 36244398 ↗ Oct 2022 |
| Modality | Monoclonal antibody | “a humanized monoclonal antibody selective for fibroblast growth factor receptor 2b (FGFR2b)” PMID 38308771 ↗ Feb 2024 |
| Route | Intravenous | “administered by IV infusion” NCT02318329 ↗ |
| Target | FCGR3A | “Low affinity immunoglobulin gamma Fc region receptor III-A binding agent” CHEMBL4802165 ↗ |
| Target | FGFR2 | “fibroblast growth factor receptor 2b (FGFR2b)” PMID 38308771 ↗ Feb 2024 |