A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer. (FORTITUDE-103)

Amgen

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Gastroesophageal Junction Cancer; Gastric Cancer

Treatments: Drug: SOX; Drug: CAPOX; Drug: Bemarituzumab; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05322577

20210099

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Part 1 Cohort A: Bemarituzumab with CAPOX

Experimental group

Treatment:

Drug: CAPOX

Drug: Bemarituzumab

Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab

Experimental group

Treatment:

Drug: Nivolumab

Drug: CAPOX

Drug: Bemarituzumab

Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab

Experimental group

Treatment:

Drug: Nivolumab

Drug: Bemarituzumab

Drug: SOX

Part 2: Bemarituzumab with SOX and Nivolumab.

Experimental group

Treatment:

Drug: Nivolumab

Drug: Bemarituzumab

Drug: SOX