Phase I Study of Metformin with Chemotherapy and Immunotherapy in Advanced Solid Tumors Evaluating Safety, Tolerability, and Maximum Dose

What this Trial Is About

Researchers are evaluating the safety of Metformin alone and combined with chemotherapy or immunotherapy in patients with advanced solid tumor cancers. This Phase I study aims to identify the toxicities of Metformin at different dose levels and determine the maximum tolerated dose when used with chemotherapy or immunotherapy. Participants are adults who have measurable disease and are suitable candidates for these treatments. Participants will receive standard chemotherapy andor immunotherapy based on their disease and stage. Initially, they will take Metformin alone for 14 days between the first and second chemotherapy cycles to assess tolerability. From the second cycle onward, Metformin will be taken daily alongside their standard cancer treatments, with doses ranging from 1000mg to 3000mg as part of a dose escalation. During the trial, participants will be monitored for dose-limiting toxicities both during the Metformin-only period and while receiving combination treatment. Researchers will assess the maximum tolerated dose and evaluate overall response rate, duration of response, and progression-free survival up to four months after treatment begins. Safety and treatment effects will be carefully tracked throughout the study, which runs until July 2028.

Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies