Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies

Part of paid clinical trials in Bay City, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT07098299
Phase
PHASE1
Status
Recruiting
Apply to this trial

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

First listed
Aug 1, 2025
Start date
Sep 18, 2025
Status verified
Jul 2026
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 (10)

FacilityCityStateZIPSite coordinators
Karmanos Cancer Institute at McLaren Bay RegionBay CityMichigan48706
989-667-2370
Karmanos Cancer Institute at McLaren ClarkstonClarkstonMichigan48346
248-922-6650
Karmanos Cancer InstituteDetroitMichigan48201
Wasif M Saif, MD
[email protected]
313-576-8706
Karmanos Cancer Institute at McLaren FlintFlintMichigan48532
810-342-3800
Karmanos Cancer Institute at McLaren Greater LansingLansingMichigan48910
517-975-9500
Karmanos Cancer Institute at McLaren Lapeer RegionLapeerMichigan48466
810-667-4994
Karmanos Cancer Institute at McLaren MacombMacombMichigan48043
586-493-7510
Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer CenterMount PleasantMichigan48858
989-772-6811
Karmanos Cancer Institute at McLaren Northern Michigan, PetoskeyPetoskeyMichigan49770
231-487-3390
Karmanos Cancer Institute at McLaren Port HuronPort HuronMichigan48060
810-982-5200

Find similar trials in Bay City, MI

By research site
Karmanos Cancer Institute at McLaren Bay Region· Bay City, MIKarmanos Cancer Institute at McLaren Clarkston· Clarkston, MIKarmanos Cancer Institute· Detroit, MIKarmanos Cancer Institute at McLaren Flint· Flint, MIKarmanos Cancer Institute at McLaren Greater Lansing· Lansing, MIKarmanos Cancer Institute at McLaren Lapeer Region· Lapeer, MI

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