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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03694522.
Locations matching your search criteria
United States
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer CenterStatus: Approved
Name Not Available
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.
Lead OrganizationFive Prime Therapeutics, Inc.