Status:
ACTIVE_NOT_RECRUITING
A Study of REC-4881 in Participants with Cancers Which Have an AXIN1 or APC Mutation
Lead Sponsor:
Recursion Pharmaceuticals Inc.
Conditions:
AXIN1 Gene Mutation
APC Gene Mutation
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advance...
Detailed Description
Approximately 60 individuals will be enrolled in this open-label Phase 2 study, allocated 1:1 between the 2 cohorts - AXIN1 mutation or APC mutation. The purpose of the study is to investigate the saf...
Eligibility Criteria
Inclusion
- 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
- 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
- Measurable disease at baseline per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Exclusion
- Received treatment with another mitogen-activated protein kinase (MEK) inhibitor within two months of first dose of REC-4881
- Left ventricular ejection fraction (LVEF) \<50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06005974
Start Date
January 15 2024
End Date
January 1 2027
Last Update
November 29 2024
Active Locations (13)
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1
Sharp Memorial Hospital
San Diego, California, United States, 92123
2
Sansum Clinic
Santa Barbara, California, United States, 93105
3
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
4
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, United States, 06360