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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Temozolomide — DRUG
  Given orally (PO)
• Tuvusertib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Sep 28, 2023

Status verified

Mar 2026

Primary completion

Mar 1, 2027

Completion

Mar 1, 2027

Study Design

Enrollment

42 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (tuvusertib, temozolomide)
  Patients receive tuvusertib PO QD) on days 1-7 and temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI as well as collection of blood samples throughout the trial. Patients also undergo a biopsy at baseline and may undergo one on study and/or at time of progression.

Primary Outcome Measure

Dose limiting toxicity and the maximum tolerated dose [ Time Frame: Up to 28 days ]

Locations (23)

Find similar trials in Irvine, CA

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