Bemarituzumab
Sponsors
Amgen Inc., Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH, Institut De Cancerologie De L Ouest, University of Chicago, Five Prime Therapeutics, Inc.
Conditions
AdenocarcinomaCervix CancerEndometrial CarcinomaFGFR2b-positiveGastric CancerGastric and Gastroesophageal Junction Cancer With FGFR2b OverexpressionGastroEsophageal CancerGastroesophageal Junction Adenocarcinoma
Phase 1
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer
CompletedNCT03343301
Start: 2017-11-30End: 2019-01-31Updated: 2024-02-28
A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)
TerminatedNCT05267470
Start: 2022-03-29End: 2024-05-28Updated: 2025-03-25
A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
Active, not recruitingNCT05322577
Start: 2022-05-17End: 2026-08-12Updated: 2025-12-05
A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
CompletedNCT05325866
Start: 2022-09-23End: 2026-01-28Updated: 2026-02-04
A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression (FORTITUDE-301)
Active, not recruitingCTIS2023-505455-44-00
Start: 2022-06-29Target: 300Updated: 2025-07-17
Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment
Not yet recruitingNCT06978062
Start: 2026-02-20End: 2029-09-28Target: 27Updated: 2025-06-05
AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer
Not yet recruitingNCT07146919
Start: 2025-10-15End: 2030-10-15Target: 87Updated: 2025-08-28
Phase 2
PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression
CompletedNCT02213289
Start: 2015-01-20End: 2020-08-20Updated: 2021-04-08
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer
CompletedNCT03694522
Start: 2018-09-14End: 2022-05-13Updated: 2024-02-28
Bemarituzumab in patients with FGFR2b-positive advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction, who failed at least one prior line of palliative chemotherapy - The IKF-AIO Phase IIa BEMARA trial
Active, not recruitingCTIS2024-512484-31-00
Start: 2025-02-28Target: 146Updated: 2026-01-06
Open-label non-randomized multicentric phase 2 study evaluating the combination of bemarituzumab + FLOT chemotherapy in perioperative setting for resectable stage cT2-T4a or N+ gastric and GEJ adenocarcinoma overexpressing FGFR2b (BEMAFLOT)
CompletedCTIS2024-514078-29-00
End: 2025-11-07Target: 49Updated: 2025-10-02
SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma
Not yet recruitingNCT07470840
Start: 2027-02-01End: 2029-06-01Target: 27Updated: 2026-03-24
Phase 3
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Active, not recruitingNCT05052801
Start: 2022-03-07End: 2026-06-20Updated: 2026-02-19
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
Active, not recruitingNCT05111626
Start: 2022-03-14End: 2027-01-29Updated: 2025-12-15
A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab plus Chemotherapy versus Placebo plus Chemotherapy in Subjects with Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression FORTITUDE-101)
Active, not recruitingCTIS2023-505457-40-00
Start: 2022-02-02Target: 327Updated: 2025-09-01
A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102)
CompletedCTIS2023-505458-16-00
Start: 2022-09-13End: 2025-10-29Target: 186Updated: 2025-10-21