Bemarituzumab in FGFR2b+ Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy

Conditions

• Metastatic Gastro-esophageal Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bemarituzumab, paclitaxel, ramucirumab — DRUG
  Cohort 2 will receive bemarituzumab plus SOC treatment with paclitaxel and ramucirumab
• bemarituzumab, irinotecan — DRUG
  Cohort 1 will receive bemarituzumab plus SOC treatment with irinotecan
• bemarituzumab, trifluridine/tipiracil — DRUG
  Cohort 3 will receive bemarituzumab plus SOC treatment with trifluridine/tipiracil

Study Details

The goal of this clinical trial is to evaluate if bemarituzumab in combination with different standard of care chemotherapies enhance tumor response in patients with FGFR2b-positive advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. The main questions are: How do patients respond to these treatments? How is the overall and the progression-free survival rate with these treatments? How is the disease control rate with these treatments? How long is the duration of response and disease stabilization with these treatments? How is the safety with these treatments? How is the quality of life with these treatments? Patients will be allocated to one of three possible treatment cohorts according to investigator's decision and current standard of care: Bemarituzumab with cohort 1: irinotecan cohort 2: paclitaxel plus ramucirumab cohort 3: trifluridine/tipiracil

Key Dates

Start date

Mar 3, 2025

Status verified

Jan 2026

Primary completion

Sep 30, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

126 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  bemarituzumab plus SOC treatment with irinotecan
• Experimental: Cohort 2
  bemarituzumab plus SOC treatment with paclitaxel plus ramucirumab
• Experimental: Cohort 3
  bemarituzumab plus SOC treatment with trifluridine/tipiracil

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: from date of enrollment to date of last response acc. to RECIST v1.1 or death due to any cause, through study completion, up to 33 months ]