NCT06680622

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

Bemarituzumab in Patients With FGFR2b-positive Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy - The IKF-AIO Phase IIa BEMARA Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-03-03
• Primary completion: 2027-09-01
• Completion: 2028-03-01
• First posted: 2024-11-08
• Last updated: 2026-01-07

Locations

35 sites across 1 country: Germany