Clinical trialNCT05691491RecruitingPhase 1/PHASE2Interventional

Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness

SponsorNational Cancer Institute (NCI)Enrollment42Advanced Malignant Solid NeoplasmAdvanced Microsatellite Stable Colorectal CarcinomaHematopoietic and Lymphatic System NeoplasmMetastatic Malignant Solid NeoplasmMetastatic Microsatellite Stable Colorectal CarcinomaStage III Colorectal Cancer AJCC v8+1 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Michael Cecchini
Yale University Cancer Center LAO
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

23 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Farshid Dayyani →
Recruiting
Uc San Diego Moores Cancer Center
La Jolla, California, United States
Active, not recruiting
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Farshid Dayyani →
Recruiting
Yale University
New Haven, Connecticut, United States
Michael Cecchini
Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Michael Cecchini
Recruiting
Memorial Hospital East
Shiloh, Illinois, United States
Active, not recruiting
University of Kansas Clinical Research Center
Fairway, Kansas, United States
Raed Al-Rajabi
Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, United States
Raed Al-Rajabi
Recruiting
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
Raed Al-Rajabi
Recruiting
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States
Raed Al-Rajabi
Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Raed Al-Rajabi
Recruiting
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States
A P. Chen
Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Active, not recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Active, not recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
Raed Al-Rajabi
Recruiting
University of Kansas Cancer Center - Lee'S Summit
Lee's Summit, Missouri, United States
Raed Al-Rajabi
Recruiting
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States
Suspended
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Active, not recruiting
Siteman Cancer Center-South County
St Louis, Missouri, United States
Active, not recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Active, not recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Abdul Rafeh Naqash
Recruiting
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Janie Y. Zhang
Recruiting
Vanderbilt University/ingram Cancer Center
Nashville, Tennessee, United States
Elizabeth J. Davis
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Temozolomide →Tuvusertib

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Sept 2023
Primary completion: 1 Mar 2027
Completion: 1 Mar 2027
Last update posted: 31 Jul 2026
Registered enrollment: 42
Registry id: NCT05691491

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.