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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

NCT06680622 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-01-07

No results posted yet for this study

Summary

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

Conditions

  • Metastatic Gastro-esophageal Adenocarcinoma

Interventions

DRUG

bemarituzumab, paclitaxel, ramucirumab

Cohort 2 will receive bemarituzumab plus SOC treatment with paclitaxel and ramucirumab

DRUG

bemarituzumab, irinotecan

Cohort 1 will receive bemarituzumab plus SOC treatment with irinotecan

DRUG

bemarituzumab, trifluridine/tipiracil

Cohort 3 will receive bemarituzumab plus SOC treatment with trifluridine/tipiracil

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Technical University of Munich

    collaborator OTHER

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Sylvie Lorenzen, Prof. Dr. · Klinikum München rechts der Isar der Technischen Universität München

  • Salah Eddin Al-Batran, Prof. Dr. · Frankfurter Institut für Klinische Krebsforschung IKF GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2027-09-30
Completion
2028-03-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06680622 on ClinicalTrials.gov