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

Part of paid clinical trials in Northport, New York.

Sponsor
Amgen
Study ID
NCT05322577
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Bemarituzumab — DRUG
    Intravenous (IV) infusion
  • CAPOX — DRUG
    CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.
  • SOX — DRUG
    SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.
  • Nivolumab — DRUG
    IV infusion.

Study Details

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.

Key Dates

Start date
May 17, 2022
Status verified
Dec 2025
Primary completion
Nov 21, 2025
Completion
Aug 12, 2026

Study Design

Enrollment
72 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) [ Time Frame: Day 1 up to Day 21 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northport Veterans Affairs Medical CenterNorthportNew York11768-

Find similar trials in Northport, NY

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Northport Veterans Affairs Medical Center· Northport, NY

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