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

Stopped early · Phase 2

Conditions studied: AXIN1 Gene Mutation, APC Gene Mutation, Solid Tumor

In brief

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 advanced or metastatic solid tumors with AXIN1 or APC mutation.

Key facts

Study ID

NCT06005974

Run by

Recursion Pharmaceuticals Inc.

People needed

18

Starts

2024-01-15

Expected to finish

2025-02-24

Last updated by the study team

2026-02-23

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sharp Memorial Hospital — San Diego, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Eastern Connecticut Hematology & Oncology Associates — Norwich, Connecticut, United States
• Medical Oncology Hematology Consultants — Newark, Delaware, United States
• Cancer Specialists of North Florida — Fleming Island, Florida, United States
• Mission Cancer And Blood — Des Moines, Iowa, United States
• American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• Hunterdon Hematology Oncology — Hillsborough, New Jersey, United States
• Avera Cancer Institute — Sioux Falls, South Dakota, United States
• Mary Crowley Cancer Research Centers — Dallas, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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