Study on REC-4881 for Treating Cancers with AXIN1 or APC Mutations
Sponsor: Recursion Pharmaceuticals Inc.
ClinicalTrials ID:NCT06005974
This clinical trial is testing a new drug, REC-4881, to see if it is safe and effective for treating advanced cancers that cannot be removed by surgery and have specific genetic mutations (AXIN1 or APC).
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Program Overview
The study aims to find out if the drug REC-4881, taken as a daily pill, is safe and effective for people with advanced cancers that have AXIN1 or APC mutations. The trial will involve about 60 participants and will take place at multiple locations. Participants will take the medication for up to two years.
Description
This clinical trial is designed to evaluate the safety and effectiveness of a new drug called REC-4881 in treating advanced cancers with specific genetic mutations, AXIN1 or APC. The study will include around 60 participants who will be divided into two groups based on their type of mutation. Each participant will take a 12 mg dose of REC-4881 daily for up to two years. The trial will help researchers understand how the drug works in the body and its potential benefits for treating these types of cancers.
Eligibility Criteria
Inclusion Criteria
- Be 55 years or older.
- Have a confirmed diagnosis of an advanced cancer that cannot be surgically removed and has an AXIN1 or APC mutation.
- If you have colorectal cancer, it must not have certain other mutations (RAS/RAF) to join the APC mutation group.
- Have tried at least one standard cancer treatment that did not work, or be unable to receive standard treatment for other reasons.
- Have measurable cancer that can be tracked using standard criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have taken another specific type of cancer drug (MEK inhibitor) within two months before starting REC-4881.
- Have a heart condition where the heart's pumping ability is less than 50% as measured by specific heart tests.
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