A Study of REC-4881 in Participants with Cancers Which Have an AXIN1 or APC Mutation

Launched by RECURSION PHARMACEUTICALS INC. · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called REC-4881 for patients with specific types of cancer that have mutations in the AXIN1 or APC genes. The trial aims to find out how safe and effective this medication is for people whose cancers are advanced and cannot be surgically removed. To participate, you need to be 55 years or older and have a confirmed diagnosis of an unresectable solid tumor with one of these mutations. Additionally, you should have experienced disease progression or have been unable to tolerate at least one standard cancer treatment.

Participants in the study will take REC-4881 as a daily pill and will be closely monitored to assess how well the treatment works and how it affects their health. It’s important to note that the trial is currently recruiting, and anyone interested should talk to their doctor to see if they meet the eligibility criteria. This trial is a chance to explore a new treatment option for those who may not have many choices left for managing their cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 55 years of age or older with histologically-confirmed unresectable, locally advanced, or metastatic solid tumor with AXIN1 or APC mutation. If a participant has colorectal cancer, then they must be RAS / RAF wild type to enroll into the APC mutant cohort
• • 2. Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment, or in the opinion of the Investigator have been considered ineligible for standard therapy
• • 3. Measurable disease at baseline per RECIST 1.1 criteria
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Exclusion Criteria:
• • 1. Received treatment with another mitogen-activated protein kinase (MEK) inhibitor within two months of first dose of REC-4881
• • 2. Left ventricular ejection fraction (LVEF) \<50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan