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

NCT05322577 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 20210099
• Study Type: interventional
• Target: 72
• Locations: 5 countries
• Sites: 42

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

Keywords

Gastric Cancer; Gastroesophageal Junction Cancer; Bemarituzumab; FGFR2b Overexpression

Outcome Measures

Primary Outcomes (3)

• Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)

  Day 1 up to Day 21

• Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

  Day 1 to end of treatment (up to approximately 1 year)

• Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  Up to 30 Months

Secondary Outcomes (14)

• Part 1: Area Under the Concentration-time Curve (AUC) of Bemarituzumab

  Day 1 to end of treatment (up to approximately 1 year)

• Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab

  Day 1 to end of treatment (up to approximately 1 year))

• Part 1: Observed Concentration at the end of a Dose Interval (Ctrough) of Bemarituzumab

  Day 1 to end of treatment (up to approximately 1 year)

• Part 1: OR per RECIST v1.1

  Up to 2 years

• Part 1: Duration of Response (DoR) per RECIST v1.1

  Up to 2 years

Study Arms (4)

Part 1 Cohort A: Bemarituzumab with CAPOX

EXPERIMENTAL

Drug: Bemarituzumab; Drug: CAPOX

Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab

EXPERIMENTAL

Drug: Bemarituzumab; Drug: CAPOX; Drug: Nivolumab

Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab

EXPERIMENTAL

Drug: Bemarituzumab; Drug: SOX; Drug: Nivolumab

Part 2: Bemarituzumab with SOX and Nivolumab.

EXPERIMENTAL

Drug: Bemarituzumab; Drug: SOX; Drug: Nivolumab

Interventions

Bemarituzumab DRUG

Intravenous (IV) infusion

Part 1 Cohort A: Bemarituzumab with CAPOX; Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab; Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab; Part 2: Bemarituzumab with SOX and Nivolumab.

CAPOX DRUG

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

Part 1 Cohort A: Bemarituzumab with CAPOX; Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab

SOX DRUG

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

Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab; Part 2: Bemarituzumab with SOX and Nivolumab.

Nivolumab DRUG

IV infusion.

Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab; Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab; Part 2: Bemarituzumab with SOX and Nivolumab.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (42)

Northport Veterans Affairs Medical Center

Northport, New York, 11768, United States

Location

Fujita Health University Hospital

Toyoake-shi, Aichi-ken, 470-1192, Japan

Location

Hirosaki University Hospital

Hirosaki-shi, Aomori, 036-8563, Japan

Location

Chiba University Hospital

Chiba, Chiba, 260-8677, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

Fukui Prefectural Hospital

Fukui-shi, Fukui, 910-8526, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Gifu University Hospital

Gifu, Gifu, 501-1194, Japan

Location

Ogaki Municipal Hospital

Ogaki-shi, Gifu, 503-8502, Japan

Location

Gunma University Hospital

Maebashi, Gunma, 371-8511, Japan

Location

Gunma Prefectural Cancer Center

Ota-shi, Gunma, 373-8550, Japan

Location

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Hiroshima, 730-8518, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

Location

Ibaraki Prefectural Central Hospital

Kasama-shi, Ibaraki, 309-1793, Japan

Location

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, 920-8530, Japan

Location

Kagawa University Hospital

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

St Marianna University Hospital

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

Kochi Health Sciences Center

Kochi, Kochi, 781-8555, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan

Location

Osaka General Medical Center

Osaka, Osaka, 558-8558, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki-shi, Osaka, 569-8686, Japan

Location

Shizuoka General Hospital

Shizuoka, Shizuoka, 420-8527, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, 135-8550, Japan

Location

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

Minato-ku, Tokyo, 108-8639, Japan

Location

Toyama University Hospital

Toyama, Toyama, 930-0194, Japan

Location

National University Hospital

Singapore, 119074, Singapore

Location

National Cancer Center

Goyang-si Gyeonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

bemarituzumab; Nivolumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 12, 2022
• Study Start: May 17, 2022
• Primary Completion: November 21, 2025
• Study Completion (Estimated): August 12, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

JP (31); SG (1); KR (7); TW (2); US (1)