Bemarituzumab + Chemotherapy for Stomach Cancer
(FORTITUDE-101 Trial)

Recruiting in Palo Alto (17 mi)

+369 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing whether adding bemarituzumab to standard chemotherapy helps patients live longer. It targets patients whose tumors have a specific marker (FGFR2b). The treatment works by blocking a protein that helps cancer cells grow.

Eligibility Criteria

Adults with advanced gastric or gastroesophageal junction cancer that can't be removed by surgery, showing high levels of FGFR2b protein. They must have a good performance status (ECOG ≤1), measurable disease per RECIST criteria, and adequate organ function. Not eligible if they have brain metastases, significant heart problems, certain eye disorders, HER2 positive cancer, recent major surgery or other treatments for their cancer.

Inclusion Criteria

I am fully active and can carry on all pre-disease activities without restriction.

I can safely receive mFOLFOX6 chemotherapy.

My tumor shows high FGFR2b levels based on a recent test.

+3 more

Exclusion Criteria

My cancer is HER2 positive.

I have had recent eye problems, including corneal defects or a corneal transplant.

I have been treated with drugs targeting the FGF-FGFR pathway.

+8 more

Participant Groups

The trial is testing the effectiveness of bemarituzumab combined with mFOLFOX6 chemotherapy versus a placebo plus mFOLFOX6 in improving survival rates. Bemarituzumab targets the FGFR2b protein overexpressed in some cancers.

2Treatment groups

Experimental Treatment

Active Control

Group I: Bemarituzumab with mFOLFOX6Experimental Treatment2 Interventions

Group II: Placebo with mFOLFOX6Active Control2 Interventions