A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
Stopped early · Phase 1/Phase 2
Conditions studied: Gastric Cancer, Gastroesophageal Junction Cancer
In brief
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.
Key facts
- Study ID
- NCT05322577
- Run by
- Amgen
- People needed
- 72
- Starts
- 2022-05-17
- Expected to finish
- 2025-11-21
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Northport Veterans Affairs Medical Center — Northport, New York, United States
- Fujita Health University Hospital — Toyoake-shi, Aichi-ken, Japan
- Hirosaki University Hospital — Hirosaki-shi, Aomori, Japan
- Chiba University Hospital — Chiba, Chiba, Japan
- National Hospital Organization Shikoku Cancer Center — Matsuyama, Ehime, Japan
- Fukui Prefectural Hospital — Fukui-shi, Fukui, Japan
- Kyushu University Hospital — Fukuoka, Fukuoka, Japan
- Fukushima Medical University Hospital — Fukushima, Fukushima, Japan
- Gifu University Hospital — Gifu, Gifu, Japan
- Ogaki Municipal Hospital — Ogaki-shi, Gifu, Japan
- Gunma University Hospital — Maebashi, Gunma, Japan
- Gunma Prefectural Cancer Center — Ota-shi, Gunma, Japan
- Hiroshima City Hiroshima Citizens Hospital — Hiroshima, Hiroshima, Japan
- Hiroshima University Hospital — Hiroshima, Hiroshima, Japan
- Ibaraki Prefectural Central Hospital — Kasama-shi, Ibaraki, Japan
- Ishikawa Prefectural Central Hospital — Kanazawa, Ishikawa-ken, Japan
- Kagawa University Hospital — Kita-gun, Kagawa-ken, Japan
- St Marianna University Hospital — Kawasaki-shi, Kanagawa, Japan
- Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center — Yokohama, Kanagawa, Japan
- Kochi Health Sciences Center — Kochi, Kochi, Japan
- Kyoto University Hospital — Kyoto, Kyoto, Japan
- Tohoku University Hospital — Sendai, Miyagi, Japan
- Okayama University Hospital — Okayama, Okayama-ken, Japan
- Osaka General Medical Center — Osaka, Osaka, Japan
- Osaka Medical and Pharmaceutical University Hospital — Takatsuki-shi, Osaka, Japan
Full record on ClinicalTrials.gov
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