OncoMatch/Clinical Trials/NCT05691491
Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
Is NCT05691491 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Temozolomide and Tuvusertib for advanced malignant solid neoplasm.
Treatment: Temozolomide · Tuvusertib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Colorectal Cancer
Biomarker criteria
Required: MGMT promoter hypermethylation
MGMT promoter hypermethylation positivity on testing / pre-screening of archival tissue
Required: MMR proficient
mismatch repair proficient / microsatellite stable
Required: MSI microsatellite stable
microsatellite stable
Disease stage
Required: Stage III, IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy (5-fluorouracil, irinotecan, oxaliplatin) — metastatic
must have received prior therapy with 1 or more systemic therapies in the metastatic setting that includes 5-fluorouracil, irinotecan, and oxaliplatin
Cannot have received: alkylating agent (temozolomide)
Patients may not have previously received temozolomide
Cannot have received: ATR inhibitor
Patients may not have previously received...an ataxia telangiectasia and rad3-related (ATR) inhibitor
Lab requirements
Blood counts
Hemoglobin >=10 g/dL (No blood transfusions within 14 days of C1D1); WBC > 3 x 10^9/L; ANC >= 1,500/mcL; Platelets >= 100,000/mcL
Kidney function
Glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2
Liver function
Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 3 x institutional ULN except for when liver metastases are present, in which case they must be <= 5 x institutional ULN
Cardiac function
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
Hemoglobin >=10 g/dL (No blood transfusions are allowed within 14 days of cycle 1 day 1 [C1D1]). White blood cells (WBC) > 3 x 10^9/L. Absolute neutrophil count >= 1,500/mcL. Platelets >= 100,000/mcL. Total bilirubin <= 1.5 x institutional upper limit of normal (ULN). Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine-aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) <= 3 x institutional ULN except for when liver metastases are present, in which case they must be <= 5 x institutional ULN. Glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC San Diego Moores Cancer Center · La Jolla, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- Yale University · New Haven, Connecticut
- Smilow Cancer Hospital Care Center-Trumbull · Trumbull, Connecticut
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