Five Prime Therapeutics has started dosing patients in the Phase l portion of the FIGHT Phase l/lll clinical trial of FPA144 in combination with chemotherapy for patients with previously untreated, advanced gastric or gastroesophageal cancer.
The open-label, safety lead-in portion of trial aims to assess the ascending doses of FPA144 in combination with the modified FOLFOX6 regimen (mFOLFOX6) to identify a recommended dose for Phase lll.
Study endpoints include safety, tolerability, and pharmacokinetic and pharmacodynamics parameters.
The trial will enrol around 21 patients with unresectable, locally advanced, or metastatic gastrointestinal cancer.
Five Prime Therapeutics senior vice-president and chief medical officer Helen Collins said: “We have seen encouraging monotherapy activity with FPA144 as a late-line treatment for gastric cancer and we believe that combining with chemotherapy in the frontline setting will provide the greatest patient benefit, as has been seen with other targeted therapies.
“Similarly, our pre-clinical data suggests that FPA144 should be additive when combined with chemotherapy.”
FPA144 is an isoform-selective, humanised monoclonal antibody currently under development as a targeted immuno-therapy for tumours that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family.
Five Prime aims to begin the randomised and controlled Phase lll portion of the FIGHT trial by mid-2018.
The trial seeks to evaluate FPA144 plus mFOLFOX6 versus placebo plus mFOLFOX6 in around 550 patients with advanced gastric or gastroesophageal cancer whose tumours overexpress FGFR2b or have FGFR2 gene amplification.
Immunohistochemistry and circulating tumor DNA tests will be used by Five Prime to identify patients who would be eligible for inclusion in the trial.
Phase lll trial’s primary endpoint is to achieve overall survival with progression-free survival, objective response rate, and safety as secondary endpoints.