Actively Recruiting
Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2025-11-06
60
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 63 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 63 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 64 1.5 x upper limit of normal (ULN). Participants with known Gilbert's syndrome who have total bilirubin level 64 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 64 5 x ULN.
- Alkaline phosphatase (ALP) < 2.5 x ULN. For participants with hepatic and/or bone metastases 64 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 will not qualify if you...
- 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 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 64 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
Research Team
W
Wasif Saif, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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