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

A Phase 2, Open Label Study of REC-4881 in Participants With Unresectable Locally Advanced or Metastatic Cancer With AXIN1 or APC Mutation

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.

Study Overview

• Status: Terminated
• Conditions: Solid Tumor; APC Gene Mutation; AXIN1 Gene Mutation
• Intervention / Treatment: Drug: REC-4881

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 safety, efficacy, and pharmacokinetics of REC-4881 for the treatment of participants with unresectable locally advanced or metastatic solid tumors with either mutation. Participants will receive treatment with REC-4881 (12mg PO daily) for up to 2 years.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology & Oncology Associates
  • Delaware
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants
  • Florida
    • Fleming Island, Florida, United States, 32003
      • Cancer Specialists of North Florida
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Mission Cancer and Blood
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • American Oncology Partners of Maryland, PA
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • Hunterdon Hematology Oncology
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Texas
    • Dallas, Texas, United States, 75231
      • Mary Crowley Cancer Research Centers
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AXIN1 Cohort; Participants will receive REC-4881 12mg PO dosed QD	Drug: REC-4881; REC-4881 4mg capsules
Experimental: APC Cohort; Participants will receive REC-4881 12mg PO dosed QD	Drug: REC-4881; REC-4881 4mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	Up to 24 months
Number of Participants with Dose Limiting Toxicities	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of response	Up to 24 months
Area Under the Plasma Concentration-time Curve (AUC) of REC-4881	pre-dose and up to 24 months
Disease Control Rate	Up to 24 months
Duration of Stable Disease	Up to 24 months
Time to Response	Up to 24 months

Collaborators and Investigators

• Sponsor: Recursion Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Solid tumor; APC; Locally advanced or metastatic; AXIN1
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis
• Other Study ID Numbers: REC-4881-221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No