Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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 facts

Study ID: NCT07098299
Run by: Barbara Ann Karmanos Cancer Institute
People needed: 60
Starts: 2025-09-18
Expected to finish: 2028-07-07
Last updated by the study team: 2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have histologically confirmed advanced solid tumor and are considered a suitable candidate for chemotherapy and/or immunotherapy or both
Are a male or female participant aged ≥ 18 years
Have provided a signed, written informed consent form
Have measurable disease per RECIST v1.1
Have adequate hematologic, renal, liver, and coagulation function as defined by the following:
Hemoglobin ≥ 8 g/dL if determined suitable by the investigator for the selected chemotherapy and/or immunotherapy regimen for the particular patient
Absolute neutrophil count (ANC) > 1500/mm3
Platelets > 75,000/mm3 if determined suitable by the investigator for the selected chemotherapy and /or immunotherapy regimen for the particular patient
Estimated Glomerular Filtration Rate (eGFR) > 45 mL/min/1.73 m2 (as described by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021 equation)
Total bilirubin ≤ 1.5 x upper limit of normal (ULN). Participants with known Gilbert's syndrome who have total bilirubin level ≤ 3 x ULN may be enrolled if deemed suitable for a particular patient by the investigator for the selected chemotherapy and/or immunotherapy regimen.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN. For participants with hepatic metastases, AST and ALT ≤ 5 x ULN.
Alkaline phosphatase (ALP) < 2.5 x ULN. For participants with hepatic and/or bone metastases ≤ 5 x ULN
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2, and suitable for chemotherapy/IO recommended by the investigator.
Participants who have experienced expected toxicity from Cycle 1 of anticancer therapy which is unlikely to recover to grade 1 or better prior to Cycle 2 (e.g., anemia, alopecia, vitiligo, endocrine dysfunction associated with IO) and may otherwise not impact the eligibility will be allowed.
Women of child-bearing potential must agree to avoid becoming pregnant and male participants should avoid impregnating a female partner or donating sperm starting at initiation of treatment up until at least 90 days after the last dose of study drug.
Have an estimated life expectancy of at least 12 weeks

You may not qualify if…

Patients who have or are any of the following exclusion criteria are not eligible for participation in the study.
Patients with uncontrolled diabetes
Patients who have received metformin must be at least five half-lives beyond such treatment (four weeks) and must not be taking metformin at the time of enrollment.
Patients with a known hypersensitivity to metformin, its excipients, its analogs, or any of its components
Patients on other antidiabetic medicines are eligible as long as adding metformin will not be contraindicated
Patients with an inability to tolerate oral medications
Women who are pregnant or lactating
Patients with clinically significant intercurrent disease including, but not limited to:
New York Heart Association Class III or IV heart failure
Myocardial infarction, unstable angina, or stroke ≤ 3 months prior to Cycle 1 Day 1
Uncontrolled arrhythmia
Clinically significant active infection requiring IV antibiotic, antiviral, or antifungal medications
Patients with other current medical or other conditions that, in the opinion of the investigator, may confound study interpretation or prevent completion of study procedures and follow-up examinations
Patients with an unwillingness or inability to comply with the study procedures required in this protocol
Patients using an investigational agent within four weeks of study entry
Patients with uncontrolled metabolic disorders or primary or secondary effects of cancer that induce a high medical risk

Where it is running

Karmanos Cancer Institute at McLaren Bay Region — Bay City, Michigan, United States (enrolling)
Karmanos Cancer Institute at McLaren Clarkston — Clarkston, Michigan, United States (enrolling)
Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
Karmanos Cancer Institute at McLaren Flint — Flint, Michigan, United States (enrolling)
Karmanos Cancer Institute at McLaren Greater Lansing — Lansing, Michigan, United States (enrolling)
Karmanos Cancer Institute at McLaren Lapeer Region — Lapeer, Michigan, United States (enrolling)
Karmanos Cancer Institute at McLaren Macomb — Macomb, Michigan, United States (enrolling)
Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center — Mount Pleasant, Michigan, United States (enrolling)
Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey — Petoskey, Michigan, United States (enrolling)
Karmanos Cancer Institute at McLaren Port Huron — Port Huron, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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