Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine

Study Overview

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

Study Description

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

  • Identifier: NCT03854110
  • Protocol Number: 19-030
  • Principal Investigator: Andrea Bullock

Recruitment Status


Contact the research team to learn more about this study.

Fields marked with asterisk (*) are required

Please verify that you are not a bot.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

If you need assistance finding a study or if you have any questions, call us at 617-667-7000