RecruitingPhase 1NCT07098299

Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies

A Phase I Dose-escalation and Metabolomics Study of Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies


Sponsor

Barbara Ann Karmanos Cancer Institute

Enrollment

60 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the safety of Metformin alone and in combination with chemotherapy or immunotherapy in patients with solid tumor cancers. The main questions it aims to answer are: * what are the toxicities of metformin at multiple dose levels * what is the maximum tolerated dose of Metformin in combination with chemotherapy or immunotherapy Participants enrolled will be treated with standard of care chemotherapy and/or immunotherapy in accordance to their disease/stage. In addition, participants will take Metformin alone for 14 days in between the first cycle of chemotherapy and the second cycle of chemotherapy to determine tolerability to the Metformin. Participants will then take Metformin daily in combination with the standard of care chemotherapy and/or Immunotherapy from cycle 2 onwards.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Metformin for people with advanced solid tumor. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

Metformin will be given for 14 days alone as a run in and then added to any standard of care chemotherapy or immunotherapy for solid tumors.


Locations(10)

Karmanos Cancer Institute at McLaren Bay Region

Bay City, Michigan, United States

Karmanos Cancer Institute at McLaren Clarkston

Clarkston, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Karmanos Cancer Institute at McLaren Flint

Flint, Michigan, United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Karmanos Cancer Institute at McLaren Lapeer Region

Lapeer, Michigan, United States

Karmanos Cancer Institute at McLaren Macomb

Macomb, Michigan, United States

Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center

Mount Pleasant, Michigan, United States

Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

Petoskey, Michigan, United States

Karmanos Cancer Institute at McLaren Port Huron

Port Huron, Michigan, United States

View Full Details on ClinicalTrials.gov

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NCT07098299


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