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Metformin with Chemotherapy/Immunotherapy for Advanced Solid Tumors

This study is looking at the safety of Metformin, a common diabetes medication, when given alone and in combination with standard chemotherapy or immunotherapy for people with advanced solid tumor cancers. The main goals are to understand any side effects of Metformin at different doses and to find the highest safe dose of Metformin when combined with these cancer treatments. You would receive your usual chemotherapy or immunotherapy, and also take Metformin for 14 days before adding it to your ongoing cancer treatment. This study is for adults aged 18 and older with advanced solid tumors that can be measured.

Study design
This study plans to enroll 60 participants with advanced solid tumors. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You would take Metformin alone for 14 days, then continue with Metformin combined with your standard chemotherapy or immunotherapy. The study will monitor for side effects during these periods.
Compensation
Not stated in the trial record.
Follow-up
Side effects will be monitored for up to 30 days after treatment ends. The maximum tolerated dose will be determined up to 4 months after treatment starts.

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NCT07098299

Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Barbara Ann Karmanos Cancer Institute
~60 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Metformin

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose Limiting Toxicities (DLTs)-Metformin only stage
Measured over From the start of Metformin run in to the end of Metformin run in. Up to 14 days
+2 more outcomes measured

Conditions

Advanced Solid Tumor

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Solid Neoplasm

NCT07098299

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Karmanos Cancer Institute

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Bay Region

    Bay City, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center

    Mount Pleasant, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Clarkston

    Clarkston, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Flint

    Flint, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Lapeer Region

    Lapeer, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Macomb

    Macomb, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Wasif Saif, M.D. · PRINCIPAL_INVESTIGATOR · Wayne State University

Who to contact

Wasif Saif, M.D.
[email protected]
(313) 576-8706
Email the study team

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Eligibility criteria

Inclusion

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:
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

Exclusion

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:
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

What this trial measures

  • Incidence of Dose Limiting Toxicities (DLTs)-Metformin only stageFrom the start of Metformin run in to the end of Metformin run in. Up to 14 days

    Adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).

  • Incidence of Dose Limiting Toxicities (DLTs)-Chemotherapy or Immunotherapy (IO) plus Metformin StageFrom start of Chemotherapy or IO plus Metformin until 30 days after the end of treatment

    Adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).

  • Determine the maximum tolerated dose (MTD) of metformin in combination with chemotherapy/IOUp to 4 months after treatment initiation

    The MTD will be defined as the dose level below the dose level at which two or more patients in the same cohort experience a DLT. If none or only one patient experiences a DLT at level 5, then dose level 5 will be defined as the MTD.