Status:
ACTIVE_NOT_RECRUITING
A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
Lead Sponsor:
Amgen
Conditions:
Gastric Cancer
Gastroesophageal Junction Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
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 combina...
Eligibility Criteria
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.
- 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.
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05322577
Start Date
May 17 2022
End Date
August 12 2026
Last Update
December 5 2025
Active Locations (42)
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1
Northport Veterans Affairs Medical Center
Northport, New York, United States, 11768
2
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, Japan, 470-1192
3
Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan, 036-8563
4
Chiba University Hospital
Chiba, Chiba, Japan, 260-8677