Advanced Solid TumorPhase 1NCT07098299
Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies
A Phase 1 study testing Metformin in people with Advanced Solid Tumor, run by Barbara Ann Karmanos Cancer Institute at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Sep 2025to 7 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Karmanos Cancer Institute at McLaren Bay Region
Bay City, Michigan, 48706
989-667-2370
- Recruiting
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, 48346
248-922-6650
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Wasif M Saif, MD, 313-576-8706, saifw@karmanos.org
- Recruiting
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, 48532
810-342-3800
- Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
517-975-9500
- Recruiting
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, 48466
810-667-4994
- Recruiting
Karmanos Cancer Institute at McLaren Macomb
Macomb, Michigan, 48043
586-493-7510
- Recruiting
Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center
Mount Pleasant, Michigan, 48858
989-772-6811
- Recruiting
Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey
Petoskey, Michigan, 49770
231-487-3390
- Recruiting
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, 48060
810-982-5200
About this study
Official title: A Phase I Dose-escalation and Metabolomics Study of Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies
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
- Advanced Solid Tumor
- Being tested
- Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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 group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin will be administered in combination with any standard chemotherapy/immunotherapy. Metformin 1000mg-3000mg day in dose escalation Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs)-Metformin only stage
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).
Measured: From the start of Metformin run in to the end of Metformin run in. Up to 14 days
Incidence of Dose Limiting Toxicities (DLTs)-Chemotherapy or Immunotherapy (IO) plus Metformin Stage
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).
Measured: From start of Chemotherapy or IO plus Metformin until 30 days after the end of treatment
Determine the maximum tolerated dose (MTD) of metformin in combination with chemotherapy/IO
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.
Measured: Up to 4 months after treatment initiation
Secondary outcomes (3)
Assessment of overall response rate (ORR)
Tumor response will be determined according to RECIST v1.1. Treatment responses will be summarized by count and percentage, and their rates will be computed along with their associated two-sided 95% confidence intervals (CIs).
Measured: Up to 4 months after treatment initiation
Assessment of Duration of Response (DOR)
Tumor response will be determined according to RECIST v1.1. The DOR is measured from the time measurement criteria are met for complete response (CR) or a partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Treatment responses will be summarized by count and percentage, and their rates will be computed along with their associated two-sided 95% confidence intervals (CIs). The distributions of time-to-event data, such as DOR and PFS will be graphically summarized using Kaplan-Meier (KM) curves, and their median and 95% CIs will be estimated using KM estimates.
Measured: Up to 4 months after treatment initiation
Assessment of Progression free survival (PFS)
Tumor response will be determined according to RECIST v1.1. Progression-free survival (PFS) is defined as the time duration from treatment start to progression time or death, whichever occurs first. Treatment responses will be summarized by count and percentage, and their rates will be computed along with their associated two-sided 95% confidence intervals (CIs). The distributions of time-to-event data, such as DOR and PFS will be graphically summarized using Kaplan-Meier (KM) curves, and their median and 95% CIs will be estimated using KM estimates.
Measured: Up to 4 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start18 Sep 2025
- Primary completion7 Jul 2027 (estimated)
- Study completion7 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wasif Saif, Barbara Ann Karmanos Cancer Institute
- Investigators
- Wasif Saif, M.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098299
- Sponsor's protocol ID
- 2024-050
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-escalation and Metabolomics Study of Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies
- ClinicalTrials.gov ID
- NCT07098299
- Acronym / sponsor ID
- 2024-050
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 7 Jul 2028 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminMetformin will be administered in combination with any standard chemotherapy/immunotherapy. Metformin 1000mg-3000mg day in dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin 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. | Drug | Metformin |
Primary outcome
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
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 Stage
Time frame: From 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/IO
Time frame: Up 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.
3 secondary outcomes
Assessment of overall response rate (ORR)
Time frame: Up to 4 months after treatment initiation
Assessment of Duration of Response (DOR)
Time frame: Up to 4 months after treatment initiation
Assessment of Progression free survival (PFS)
Time frame: Up to 4 months after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wasif Saif, M.D. principal investigator
Wayne State University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin in people with Advanced Solid Tumor, run by Barbara Ann Karmanos Cancer Institute at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wasif Saif, M.D. ((313) 576-8706, saifw@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.