NCT05322577TerminatedPhase 1
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).
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Amgen
- Enrollment
- 72
- Locations
- 42
- Primary Endpoint
- Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •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.
Arms & Interventions
Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab
Experimental
Intervention: SOX (Drug)
Part 1 Cohort A: Bemarituzumab with CAPOX
Experimental
Intervention: CAPOX (Drug)
Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab
Experimental
Intervention: CAPOX (Drug)
Part 2: Bemarituzumab with SOX and Nivolumab.
Experimental
Intervention: SOX (Drug)
Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab
Experimental
Intervention: Nivolumab (Drug)
Part 1 Cohort A: Bemarituzumab with CAPOX
Experimental
Intervention: Bemarituzumab (Drug)
Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab
Experimental
Intervention: Bemarituzumab (Drug)
Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab
Experimental
Intervention: Bemarituzumab (Drug)
Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab
Experimental
Intervention: Nivolumab (Drug)
Part 2: Bemarituzumab with SOX and Nivolumab.
Experimental
Intervention: Nivolumab (Drug)
Part 2: Bemarituzumab with SOX and Nivolumab.
Experimental
Intervention: Bemarituzumab (Drug)
Outcomes
Primary Outcomes
Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Time Frame: Day 1 to end of treatment (up to approximately 1 year)
Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Time Frame: Day 1 up to Day 21
Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame: Up to 30 Months
Secondary Outcomes
- Part 1: Area Under the Concentration-time Curve (AUC) of Bemarituzumab(Day 1 to end of treatment (up to approximately 1 year))
- Part 1: Duration of Response (DoR) per RECIST v1.1(Up to 2 years)
- Part 2: PFS per RECIST v1.1(Up to 30 months)
- 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 2: Number of Participants Who Experience TEAEs(Up to 30 months)
- Part 2: DoR per RECIST v1.1(Up to 30 months)
- Part 2: Time to Response (TTR) per RECIST v1.1(Up to 30 months)
- Part 1: OR per RECIST v1.1(Up to 2 years)
- Part 1: Progression-free Survival (PFS) per RECIST v1.1(Up to 2 years)
- Part 1: Overall Survival (OS)(Up to 2 years)
- Part 2: Disease Control (DC) per RECIST v1.1(Up to 30 months)
- Part 1: Disease Control Rate (DCR)(Up to 2 years)
- Part 2: OS(Up to 30 months)
Investigators
Study Sites (42)
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