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Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies

NCT07098299 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-06

No results posted yet for this study

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 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

Interventions

DRUG

Metformin

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.

Sponsors & Collaborators

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-18
Primary Completion
2027-07-07
Completion
2028-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07098299 on ClinicalTrials.gov