Actively Recruiting
Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
58
Participants Needed
23
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a confirmed diagnosis of metastatic advanced cancer.
- In dose escalation, patients with solid tumors positive for MGMT promoter hypermethylation or extracranial solid tumors where temozolomide is standard care.
- Phase 2 includes only mismatch repair proficient/microsatellite stable colorectal cancer patients with MGMT promoter hypermethylation.
- Patients must have progressed after available therapies or be intolerant/refuse standard treatment; no prior temozolomide or ATR inhibitor use.
- For phase 2 colorectal cancer patients, prior treatment with 5-fluorouracil, irinotecan, and oxaliplatin is required.
- Age 18 years or older.
- Measurable disease on CT or MRI per RECIST v1.1.
- ECOG performance status 0 to 2 or Karnofsky 60% or higher.
- Adequate blood counts and organ function.
- HIV patients on effective therapy with undetectable viral load eligible.
- Controlled hepatitis B or treated hepatitis C infection.
- Patients with treated brain metastases stable for 4 weeks.
- Patients with prior or concurrent malignancies not interfering with study.
- Cardiac function class 2B or better.
- Women and men must agree to use contraception during and after treatment.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Patients not recovered from prior cancer therapy side effects greater than grade 1, except alopecia and neuropathy up to grade 2.
- History of allergic reaction to temozolomide, M1774, or similar compounds.
- Uncontrolled illnesses.
- Pregnant or breastfeeding women.
- History of ataxia telangiectasia.
- Unable to swallow oral medication or with gastrointestinal disorders affecting absorption.
- Cannot discontinue proton-pump inhibitors; restrictions on other acid-reducing medications.
- Extensive radiation involving more than 30% of bone marrow.
- QTcF interval greater than 480 ms on ECG.
AI-Screening
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Trial Site Locations
Total: 23 locations
1
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Active, Not Recruiting
3
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
4
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
5
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
6
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
7
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
8
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
9
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
10
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
11
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
12
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States, 20892
Actively Recruiting
13
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
14
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
15
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
16
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
17
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States, 64116
Suspended
18
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
19
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
20
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
21
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
22
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
23
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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