RecruitingPhase 1Phase 2NCT05691491

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

A Phase 1/2 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774

Sponsor

National Cancer Institute (NCI)

Enrollment

58 participants

Start Date

Sep 28, 2023

Study Type

INTERVENTIONAL

Conditions

Hematopoietic and Lymphatic System Neoplasm Metastatic Malignant Solid Neoplasm Stage IV Colorectal Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Advanced Malignant Solid Neoplasm Metastatic Microsatellite Stable Colorectal Carcinoma Advanced Microsatellite Stable Colorectal Carcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two experimental cancer drugs — temozolomide (a chemotherapy) and M1774 (an ATR inhibitor) — in people with advanced solid tumors, with a focus on colorectal cancer that has a specific genetic marker (MGMT methylation). **You may be eligible if...** - You are 18 or older - You have a confirmed advanced (metastatic) solid tumor - For the dose escalation phase: your tumor has MGMT promoter methylation, OR your cancer type is one where temozolomide is already a standard option (like neuroendocrine tumors, small cell lung cancer, melanoma, or soft tissue sarcoma) - For the Phase 2 portion: you have mismatch repair-proficient (MSS) colorectal cancer with MGMT methylation, after at least one prior treatment - You have not previously received temozolomide or an ATR inhibitor - Your tumor must be safely accessible for a biopsy **You may NOT be eligible if...** - You have previously taken temozolomide or an ATR inhibitor - Your tumor is not accessible for a mandatory biopsy - Your organ function is significantly impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGTemozolomide

Given orally (PO)

DRUGTuvusertib

Given PO

Locations(23)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Yale University

New Haven, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

Memorial Hospital East

Shiloh, Illinois, United States

University of Kansas Clinical Research Center

Fairway, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT05691491

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