Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
Recruiting
Phase 1
Phase 2
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 42 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
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About This Trial
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 agen…
Trial Locations
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Eligibility Criteria
Inclusion 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 testing / pre-screening of arc…
Contacts
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