A Trial to Evaluate Safety, Tolerability, and Preliminary Efficacy of Misetionamide (GP-2250) as Monotherapy or in Combination With Gemcitabine

Part 2 of the trial will use a 3+3 dose escalation design. Subjects will continue to receive treatment until disease progression assessed by RECIST V1.1 criteria, clinical disease progression as assessed by the Investigator, unacceptable toxicity, subject request for withdrawal or lost to follow-up, Investigator assessment that risk outweighs benefit or study closure by the Sponsor. Part 2 will study PROC patients with disease progression within 6 months of the last dose of platinum-based chemotherapy and maximum of 2 prior regimens with at least one regimen causing the patient to meet the definition of platinum resistance.