Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine
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
A Phase 1/2 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GP-2250 in Combination with Gemcitabine in Subjects with Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma Who Have Progressed on Prior Treatment with FOLFIRINOX Chemotherapy
- ClinicalTrials.gov Identifier: NCT03854110
- Protocol Number: 19-030
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