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Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies
Sponsor: Barbara Ann Karmanos Cancer Institute
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
2026-07-24
Healthy Volunteers
No
Conditions
Interventions
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 (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