At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic advanced cancer
- ✓Dose escalation: MGMT promoter hypermethylation positivity OR extracranial solid tumor where TMZ is standard of care (neuroendocrine, small cell lung cancer, melanoma, soft tissue sarcoma)
- ✓Colorectal cancer patients must be mismatch repair proficient/microsatellite stable
- ✓Phase 2: only microsatellite stable colorectal cancer with MGMT promoter hypermethylation positivity
- ✕Unrecovered adverse events from prior anti-cancer therapy with residual toxicities >grade 1 (except alopecia and neuropathy ≤grade 2)
- ✕Allergic reactions or hypersensitivity to compounds similar to M1774 or temozolomide, including dacarbazine
- ✕Uncontrolled intercurrent illness
- ✕Pregnant women excluded due to teratogenic/abortifacient potential of M1774 and temozolomide
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774
In Brief
A Phase 1 clinical trial evaluating Biopsy Procedure, Biospecimen Collection, and 4 other interventions for Advanced Malignant Solid Neoplasm and 6 related conditions. Currently recruiting, targeting 42 participants across 23 sites.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
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.
Interventions
Undergo biopsy
Undergo collection of blood samples
Undergo CT scan
Undergo MRI
Given orally (PO)
Given PO