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RECRUITING
NCT07098299
PHASE1

Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies

Sponsor: Barbara Ann Karmanos Cancer Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-09-18

Completion Date

2028-07-07

Last Updated

2025-11-06

Healthy Volunteers

No

Interventions

DRUG

Metformin

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 (1)

Karmanos Cancer Institute

Detroit, Michigan, United States