Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This trial will consist of 2 parts. Phase 1 will use a Bayesian Optimal Interval (BOIN) dose
escalation design of GP-2250 as intravenous single-dose monotherapy, followed by combination
therapy with gemcitabine in subjects with advanced pancreatic cancer. A Simon Two-Stage
Design (Phase 2) will follow this to assess preliminary clinical activity of GP-2250 in
combination with gemcitabine at the recommended Phase 2 dose (RP2D) in subjects with advanced
pancreatic cancer previously treated with FOLFIRINOX but never exposed to therapeutic
gemcitabine