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Recruiting Phase 1 Interventional

Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies

ClinicalTrials.gov ID: NCT07098299

Public ClinicalTrials.gov record NCT07098299. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 4, 2026, 6:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I Dose-escalation and Metabolomics Study of Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT07098299
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Enrollment
60 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 18, 2025 (Actual)
Primary completion
Jul 7, 2027 (Estimated)
Completion
Jul 7, 2028 (Estimated)
Last update posted
Jul 24, 2026

2025 – 2028

United States locations

U.S. sites
10
U.S. states
1
U.S. cities
10
Facility City State ZIP Site status
Karmanos Cancer Institute at McLaren Bay Region Bay City Michigan 48706 Recruiting
Karmanos Cancer Institute at McLaren Clarkston Clarkston Michigan 48346 Recruiting
Karmanos Cancer Institute Detroit Michigan 48201 Recruiting
Karmanos Cancer Institute at McLaren Flint Flint Michigan 48532 Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan 48910 Recruiting
Karmanos Cancer Institute at McLaren Lapeer Region Lapeer Michigan 48466 Recruiting
Karmanos Cancer Institute at McLaren Macomb Macomb Michigan 48043 Recruiting
Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center Mount Pleasant Michigan 48858 Recruiting
Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey Petoskey Michigan 49770 Recruiting
Karmanos Cancer Institute at McLaren Port Huron Port Huron Michigan 48060 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07098299, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 24, 2026 · Synced Oct 4, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07098299 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →