A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
Megadott ok: Sponsor Decision
Key facts
- Where
- Chiba, Chuo Ku, Fukui-shi, Fukuoka, Fukushima, Gifu, Hirosaki-shi, Hiroshima, Kanazawa, Kasama-Shi, Kawasaki-shi, Kita-gun, Kochi, Koto-ku, Kyoto, Maebashi, Matsuyama, Minato-ku, Ogaki-shi, Okayama, Osaka, Ota-Shi, Sendai, Shimotsuga-gun, Shizuoka, Sunto-gun, Takatsuki-shi, Toyama, Toyoake-shi és Yokohama, JapánSee the 31 sites
- Phase
- 1/2. fázis
Where in Japán
- Chiba University HospitalChiba, JapánNo longer taking part
- National Cancer Center HospitalChuo Ku, JapánNo longer taking part
- Fukui Prefectural HospitalFukui-shi, JapánNo longer taking part
- Kyushu University HospitalFukuoka, JapánNo longer taking part
- Fukushima Medical University HospitalFukushima, JapánNo longer taking part
- Gifu University HospitalGifu, JapánNo longer taking part
- Hirosaki University HospitalHirosaki-shi, JapánNo longer taking part
- Hiroshima City Hiroshima Citizens HospitalHiroshima, JapánNo longer taking part
- Hiroshima University HospitalHiroshima, JapánNo longer taking part
- Ishikawa Prefectural Central HospitalKanazawa, JapánNo longer taking part
- Ibaraki Prefectural Central HospitalKasama-Shi, JapánNo longer taking part
- St. Marianna University HospitalKawasaki-shi, JapánNo longer taking part
- Kagawa University HospitalKita-gun, JapánNo longer taking part
- Kochi Health Sciences CenterKochi, JapánNo longer taking part
- The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchKoto-ku, JapánNo longer taking part
- Kyoto University HospitalKyoto, JapánNo longer taking part
- Gunma University HospitalMaebashi, JapánNo longer taking part
- National Hospital Organization Shikoku Cancer CenterMatsuyama, JapánNo longer taking part
- IMSUT Hospital, The Institute of Medical Science, The University of TokyoMinato-ku, JapánNo longer taking part
- Ogaki Municipal HospitalOgaki-shi, JapánNo longer taking part
- Okayama University HospitalOkayama, JapánNo longer taking part
- Osaka General Medical CenterOsaka, JapánNo longer taking part
- Gunma Prefectural Cancer CenterOta-Shi, JapánNo longer taking part
- Tohoku University HospitalSendai, JapánNo longer taking part
- Dokkyo Medical University HospitalShimotsuga-gun, JapánNo longer taking part
- Shizuoka General HospitalShizuoka, JapánNo longer taking part
- Shizuoka Cancer CenterSunto-gun, JapánNo longer taking part
- Osaka Medical and Pharmaceutical University HospitalTakatsuki-shi, JapánNo longer taking part
- Toyama University HospitalToyama, JapánNo longer taking part
- Fujita Health University HospitalToyoake-shi, JapánNo longer taking part
- Kanagawa Prefectural Hospital Organization Kanagawa Cancer CenterYokohama, JapánNo longer taking part
Trial details
- Who runs it
- Amgen
- Trial code
- NCT05322577
- Record updated
- 2026. július 29.
- Original description
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.Read full original descriptionShow less
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).
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.
Inclusion: 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: 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; Major surgery or other investigational study within 28 days of first study treatment dose; Palliative radiotherapy within 14 days of first study treatment dose; Untreated or symptomatic central nervous system (CNS) disease or brain metastases; Clinically significant cardiac disease; Other malignancy within the last 2 years (exceptions for definitively treated disease); Chronic or systemic ophthalmological disorders; 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; Known human epidermal growth factor receptor 2 (HER2) positive; Peripheral sensory neuropathy greater than or equal to Grade 2.