Clinical trial · Interventional
A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
The main objectives of this study are to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies, and to evaluate the efficacy of bemarituzumab in combination with S-1 and oxaliplatin (SOX) and nivolumab as assessed by objective response.
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 Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bemarituzumab | Drug | — | UNRESOLVED |
| CAPOX | Drug | CAPOX Regimen | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| SOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1 Cohort A: Bemarituzumab with CAPOX
- interventionNames
- Drug: Bemarituzumab
- Drug: CAPOX
- type
- EXPERIMENTAL
- label
- Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab
- interventionNames
- Drug: Bemarituzumab
- Drug: CAPOX
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab
- interventionNames
- Drug: Bemarituzumab
- Drug: SOX
- Drug: Nivolumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amendable to curative therapy. * Ability to provide tumor sample, either archival (obtained within 6 months to joining study) or fresh biopsy. * For certain arms for Part 1, FGFR2b overexpression positive defined as any FGFR2b 2+/3+ TC determined by centrally performed immunohistochemistry (IHC), based on tumor sample provided. * For Part 2, FGFR2b overexpression positive defined as FGFR2b ≥10% 2+/3+ TC determined by centrally performed IHC testing, based on tumor sample provided. * Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1. * Measurable or non-measurable disease as long as evaluable by Response Evaluation Criteria Solid Tumors (RECIST) version 1.1 * Participant has no contradictions to CAPOX/SOX plus or minus nivolumab. * Adequate organ function. * For Part 2, measurable disease according to RECIST v1.1. Exclusion Criteria: * Prior treatment for metastatic or unresectable disease (Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose). * 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 of first study treatment dose. * Palliative radiotherapy within 14 days of first study treatment dose. * Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. * History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids.
References
Publications (0)
Data not yet available