Temozolomide and M1774 for Advanced Colorectal Cancer

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.
Ready to participate?

Review the details below, then apply to join this clinical 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
Who this trial is looking for

This trial is looking for patients with advanced colorectal cancer that has spread to other parts of the body. Participants will take the drugs temozolomide and M1774 to see how well they work together and what side effects they may cause.

Are You a Good Fit for This Trial?
Must not be taking TemozolomideATR inhibitors

You may be able to join if

  • I have been diagnosed with advanced colorectal cancer that has spread.
  • I am at least 18 years old.
  • I have measurable cancer that can be seen on scans.
  • I have already received standard treatments for my cancer.
  • I have a specific type of tumor with certain genetic markers.
  • I can provide a biopsy sample from my tumor.
  • I have recovered from any serious side effects of previous treatments.
  • I am willing to use contraception during the study.

You may not be able to join if

  • I am pregnant or breastfeeding.
  • I have not recovered from side effects of past cancer treatments.
  • I have a history of severe allergic reactions to similar drugs.
  • I have uncontrolled health problems.
  • I have a current serious heart condition.
  • I have had brain metastases that have progressed recently.
  • I have a history of certain liver issues.
  • I have been diagnosed with certain other cancers that might interfere.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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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