Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT07098299
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 18, 2025
Status verified
Nov 2025
Primary completion
Jul 7, 2027
Completion
Jul 7, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin
    Metformin will be administered in combination with any standard chemotherapy/immunotherapy. Metformin 1000mg-3000mg day in dose escalation

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs)-Metformin only stage [ Time Frame: From the start of Metformin run in to the end of Metformin run in. Up to 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201
Wasif M Saif, MD
[email protected]
313-576-8706

Find similar trials in Detroit, MI

By research site
Karmanos Cancer Institute· Detroit, MI

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