Rafael Pharmaceuticals, Inc. announced that its collaboration with Michigan Medicine to proceed with a Phase 1b/2 clinical trial of CPI-613® (devimistat) in combination with gemcitabine and cisplatin for patients with biliary tract cancer. The study will be a multicenter randomized trial of gemcitabine and cisplatin with or without devimistat as a first-line therapy for patients with locally advanced, unresectable or metastatic biliary tract cancer who have had no prior treatment. The goal of the Phase 1b part of the trial will be to identify the maximum tolerated dose (MTD), or the higher dose of devimistat that does not cause side effects, when given in combination with gemcitabine and cisplatin. This will determine the recommended dose for the randomized Phase 2 part of the trial. The goal of Phase 2 will be to then determine the efficacy of devimistat in combination with gemcitabine and cisplatin as compared with the combination chemotherapy alone. An estimated 68 to 78 patients will be enrolled in the study.