Drug

Bemarituzumab

In clinical development

ClassFibroblast growth factor receptor 2 inhibitorEmerging researchLate-stage development

RxNorm2529831 ChEMBLCHEMBL4802165UNIIRJW23BQ0KW

Research papers

Active clinical trials

Protein targets

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-04-26Completed · ClinicalTrials.gov

A Phase II Multicenter Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anlotinib and Bimepolizumab in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

Clinical trial2026-03-24Results expected Q1 2029 · ClinicalTrials.gov

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)

Clinical trial2026-01-28Terminated · ClinicalTrials.gov

A Phase 1b/2 Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetics of Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer (FORTITUDE-103).

Clinical trial2025-11-21Primary completion · ClinicalTrials.gov

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

Clinical trial2025-10-14Primary completion · ClinicalTrials.gov

An Open-label, Multi-centre, Phase 1b Safety and Feasibility Study for the Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (NeoBEMA)

Clinical trial2025-06-05Results expected Q3 2028 · ClinicalTrials.gov

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Bemarituzumab Monotherapy and Combination With Other Anti-Cancer Therapy in Subjects With Squamous-Cell Non-Small-Cell Lung Cancer (FORTITUDE-201)

Clinical trial2024-05-28Terminated · ClinicalTrials.gov

FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1

Clinical trial2024-02-28Results posted · ClinicalTrials.gov

FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 2 Preceded by Dose Finding in Phase 1

Clinical trial2024-02-28Results posted · ClinicalTrials.gov

Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial.

Research2024-02-03Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association

PANGEA: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma

Clinical trial2021-04-08Results posted · ClinicalTrials.gov

A Multicenter, Open-label Phase I/II Trial Aiming to Assess the Safety and Clinical Activity of Bemarituzumab + Bevacizumab in Advanced/Metastatic Gynecological Cancer Overexpressing FGFR2b

Clinical trial2030-10-15Withdrawn · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Bemarituzumab

RxNorm CUI

2529831

ChEMBL ID

CHEMBL4802165

UNII

RJW23BQ0KW

Primary mechanism

Fibroblast growth factor receptor 2 inhibitor

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Fibroblast growth factor receptor 2

FGFR2 · P21802

INHIBITORFibroblast growth factor receptor 2 inhibitor

Low affinity immunoglobulin gamma Fc region receptor III-A

FCGR3A · P08637

BINDING AGENTLow affinity immunoglobulin gamma Fc region receptor III-A binding agent

Clinical trials

11 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 11

Phase 13Phase 1 / 23Phase 23Phase 32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Active, not recruitingPH IIIAmgenn=5152027

CompletedPH IIIAmgenn=5472026

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH IIIAmgenn=5472026

CompletedPH IIFive Prime Therapeutics, Inc.n=1552022

PANGEA: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma

CompletedPH IIUniversity of Chicagon=802020

CompletedPH IFive Prime Therapeutics, Inc.n=122019

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial.

Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2024 · 50 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Fluorouracil

Studied across 3 of the same disease areas as Bemarituzumab in the shared literature.

3 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials