FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1
FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1
The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.
Study FPA144-004 is a phase 1/2, multicenter, global, double-blind, randomized, controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of bemarituzumab in combination with mFOLFOX6, compared with placebo in combination with mFOLFOX6, in adults with unresectable, locally advanced, or metastatic gastric cancer including cancer of the gastroesophageal junction (GEJ).
This study includes a Phase 1 safety run-in portion and a Phase 2 portion. The Phase 1 safety run-in is an open-label dose-escalation of bemarituzumab + mFOLFOX6 in patients with GI tumors (not FGFR2 selected) that is reported separately (NCT03343301).
The Phase 2 portion of the study (to follow the Phase 1 safety run-in) is described in this record.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Greenbrae, California 94904, United States
Santa Monica, California 90404, United States
Plainville, Connecticut 06062, United States
Rochester, New York 14642, United States
White Plains, New York 10601, United States
Bethlehem, Pennsylvania 18015, United States
South Salt Lake, Utah 84106, United States
Berlin, 12559, Germany
Frankfurt am Main, 60488, Germany
Oberpfalz, 92637, Germany
Budapest, Hungary
Kita-gun, Kagawa-ken 761-0793, Japan
Bielsko-Biala, 43-300, Poland
Olsztyn, 10-228, Poland
Warsaw, 04-141, Poland
Warsaw, Poland
Constanța, 900591, Romania
Daegu, Gyeongsangbuk-do, South Korea
Servilla, 41009, Spain
Atakum, 55200, Turkey (Türkiye)