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

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 n

Trial Details

NCT ID
NCT05691491
Phase
PHASE1 / PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Temozolomide
  • Tuvusertib
Locations (sample)
  • Irvine, California, United States|33.66946,-117.82311
  • La Jolla, California, United States|32.84727,-117.2742
  • Orange, California, United States|33.78779,-117.85311
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Trumbull, Connecticut, United States|41.24287,-73.20067

Key Eligibility Criteria

  • Patients must have histologically or cytologically confirmed diagnosis of metastatic advanced cancer.
  • In dose escalation, any solid tumor patients with either O6-methylguanine DNA methyltransferase (MGMT) promoter hypermethylation positivity on test…
  • In phase 2, only patients with mismatch repair proficient / microsatellite stable colorectal cancer that have MGMT promoter hypermethylation positi…
  • In dose escalation, patients must have progressed after treatment with all available therapies including immunotherapies for metastatic disease tha…

For full eligibility, visit ClinicalTrials.gov.

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