Clinical trial · Interventional
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bemarituzumab | Drug | — | UNRESOLVED |
| mFOLFOX6 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bemarituzumab with mFOLFOX6
- interventionNames
- Drug: Bemarituzumab
- Drug: mFOLFOX6
- type
- ACTIVE_COMPARATOR
- label
- Placebo with mFOLFOX6
- interventionNames
- Drug: mFOLFOX6
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Up to approximately 3.5 years
- description
- Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Secondary outcomes (21)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy * Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy * Eastern Cooperative Oncology Group (ECOG) less than or equal to 1 * Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1 * Participant has no contraindications to mFOLFOX6 chemotherapy * Adequate organ and bone marrow function: * absolute neutrophil count greater than or equal to 1.5 times 10\^9/L * platelet count greater than or equal to 100 times 10\^9/L * hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease) * calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault (\[140 - Age\]) × Mass \[kg\]/\[72 × Creatinine mg/dL\]) (x 0.85 if female) * international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment Exclusion Criteria: * Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment) * Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway * Known human epidermal growth factor receptor 2 (HER2) positive * Untreated or symptomatic central nervous system (CNS) disease or brain metastases * Peripheral sensory neuropathy greater than or equal to Grade 2 * Clinically significant cardiac disease * Other malignancy within the last 2 years (exceptions for definitively treated disease) * Chronic or systemic ophthalmological disorders * Major surgery or other investigational study within 28 days prior to first dose of study treatment * Palliative radiotherapy within 14 days prior to the first dose of study treatment * Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
References
Publications (4)
- BACKGROUNDRha SY, Zhang Y, Elme A, Pazo Cid R, Alacacioglu A, Ziogas DC, Shitara K, Ranceva A, Nemecek R, Santoro A, Calderon CA, Korphaisarn K, Davis T, Zahlten-Kuemeli A, Conn C, Tan M, Honeycutt H, Wainberg ZA. Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial. JCO Precis Oncol. 2025 Jan;9:e2400710. doi: 10.1200/PO-24-00710. Epub 2025 Jan 24. PMID 39854659
- BACKGROUNDFarooq AV, Kaur S, Hundal P, Burke M, Sulaiman R, Zahlten-Kumeli A, Raoof S, Li Z, Murias Dos Santos T, Huang XJ, Colby K. Advancing Ocular Safety Profile Assessment: A Novel Grading Scale for Ocular Adverse Reactions Associated with Bemarituzumab. Ophthalmol Ther. 2025 Jul;14(7):1349-1356. doi: 10.1007/s40123-025-01139-6. Epub 2025 May 12. PMID 40355729
- DERIVEDYu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036. PMID 40341124
- DERIVEDWainberg ZA, Kang YK, Lee KW, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Zahlten-Kumeli A, Taylor K, Enzinger PC. 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. 2024 May;27(3):558-570. doi: 10.1007/s10120-024-01466-w. Epub 2024 Feb 3. PMID 38308771