Study on the Safety and Effectiveness of Combining Temozolomide and M1774 for Treating Advanced Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05691491

Provider View

This clinical trial is testing a new combination of two anti-cancer drugs, Temozolomide and M1774, to see if they are safe and effective in treating advanced cancers that have spread. The study aims to find the best dose and observe how well the drugs work together to shrink or stabilize tumors.

Patient Parameters

Program Overview

This study is exploring the combination of two drugs, Temozolomide and M1774, to treat advanced cancers that have spread from their original site. Temozolomide works by damaging the DNA of cancer cells, which may kill them or slow their growth. M1774 may stop cancer cells from growing by blocking certain enzymes. The study aims to find the safest and most effective dose of these drugs when used together and to see if this combination can better control cancer compared to Temozolomide alone.

Description

The main goal of this study is to find the highest dose of Temozolomide and M1774 that patients can tolerate without severe side effects. Researchers will also look at how well the drugs work in shrinking tumors and improving survival rates. The study will also explore how certain genetic factors in tumors might affect treatment outcomes.

Participants will take M1774 by mouth once a day for the first seven days of each 28-day cycle, and Temozolomide by mouth once a day for the first five days. The treatment cycles will continue as long as the cancer does not progress and side effects are manageable. Throughout the study, participants will have regular CT and MRI scans, blood tests, and possibly tumor biopsies to monitor their response to the treatment.

After finishing the treatment, participants will have follow-up visits at four weeks, and then every three months for up to two years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced cancer that has spread.
  • For dose escalation, any solid tumor with specific genetic markers or where Temozolomide is a standard treatment.
  • For phase 2, only certain colorectal cancers with specific genetic markers.
  • Must have tried all available treatments for their cancer or be unable to tolerate them.
  • Must be 18 years or older.
  • Must have measurable disease on scans.
  • Must be in good general health with a performance status of 0 to 2.
  • Must have adequate blood counts and organ function.
  • Must not have received Temozolomide or similar drugs before.
  • Must agree to use effective birth control during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have unresolved side effects from previous cancer treatments, except for mild hair loss or nerve damage.
  • Cannot have allergies to similar drugs.
  • Cannot have uncontrolled illnesses.
  • Cannot be pregnant or breastfeeding.
  • Cannot have a history of certain genetic disorders.
  • Must be able to swallow pills and not have digestive issues that affect drug absorption.
  • Cannot take certain stomach medications during the study.
  • Cannot have had extensive radiation therapy affecting bone marrow.
  • Cannot have certain heart conditions.

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