A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.

NCT ID: NCT05322577

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2026-08-12

Brief Summary

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

Gastric Cancer; Gastroesophageal Junction Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1 Cohort A: Bemarituzumab with CAPOX

Group Type: EXPERIMENTAL

Bemarituzumab

Intervention Type: DRUG

Intravenous (IV) infusion

CAPOX

Intervention Type: DRUG

CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.

Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab

Group Type: EXPERIMENTAL

Bemarituzumab

Intervention Type: DRUG

Intravenous (IV) infusion

CAPOX

Intervention Type: DRUG

CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.

Nivolumab

Intervention Type: DRUG

IV infusion.

Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab

Group Type: EXPERIMENTAL

Bemarituzumab

Intervention Type: DRUG

Intravenous (IV) infusion

SOX

Intervention Type: DRUG

SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.

Nivolumab

Intervention Type: DRUG

IV infusion.

Part 2: Bemarituzumab with SOX and Nivolumab.

Group Type: EXPERIMENTAL

Bemarituzumab

Intervention Type: DRUG

Intravenous (IV) infusion

SOX

Intervention Type: DRUG

SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.

Nivolumab

Intervention Type: DRUG

IV infusion.

Interventions

Bemarituzumab

Intravenous (IV) infusion

Intervention Type: DRUG

CAPOX

CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.

Intervention Type: DRUG

SOX

SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.

Intervention Type: DRUG

Nivolumab

IV infusion.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

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

Shizuoka General Hospital

Shizuoka, Shizuoka, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

IMSUT Hospital, The Institute of Medical Science The University of Tokyo

Minato-ku, Tokyo, Japan

Toyama University Hospital

Toyama, Toyama, Japan

National University Hospital

Singapore, , Singapore

National Cancer Center

Goyang-si Gyeonggi-do, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

United States; Japan; Singapore; South Korea; Taiwan

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20210099

Identifier Type: -

Identifier Source: org_study_id