Phase 2 Study of Devimistat with Hydroxychloroquine and 5-Fluorouracil or Gemcitabine for Advanced Chemotherapy-Resistant Solid Tumors Including Colorectal, Pancreatic, and Others

What this Trial Is About

Researchers are evaluating the combination of CPI-613 devimistat with hydroxychloroquine HCQ and either 5-fluorouracil 5-FU or gemcitabine in patients with advanced solid tumors that have spread or not responded to chemotherapy. This phase II trial aims to estimate the overall response rate and assess progression-free survival, overall survival, duration of response, safety, and tolerability. The study includes patients with colorectal, pancreatic, gastroesophageal, urothelial, ovarian, non-small cell lung, and biliary cancers. Participants are assigned to one of three groups based on cancer type and receive a combination of intravenous devimistat plus either 5-FU or gemcitabine, along with oral hydroxychloroquine. Patients with colorectal, pancreatic, or gastroesophageal cancers receive devimistat, 5-FU, and HCQ. Those with urothelial, ovarian, non-small cell lung, or biliary tumors receive devimistat, gemcitabine, and HCQ or devimistat with gemcitabine or HCQ. Treatment involves multiple cycles with blood sample collection and imaging using CT or MRI to monitor disease. During the study, participants undergo regular imaging scans and blood collections for molecular and metabolic analyses. Researchers measure tumor response, time to disease progression, survival times, and safety outcomes up to 24 months. The study also monitors adverse events for 30 days after treatment. Patients must be available and willing to comply with study procedures, including consenting and attending all visits for the duration of the trial, which extends through the treatment and follow-up periods.

CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors