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

NCT06005974 | Terminated Phase 2 FDA Drug

• 1 other identifier: REC-4881-221
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 13

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 advanced or metastatic solid tumors with AXIN1 or APC mutation.

Conditions

AXIN1 Gene Mutation; APC Gene Mutation; Solid Tumor

Keywords

AXIN1; APC; Locally advanced or metastatic; Solid tumor

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Dose Limiting Toxicities

  Up to 24 months

• Objective Response Rate

  Up to 24 months

Secondary Outcomes (5)

• 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 response

  Up to 24 months

• Duration of Stable Disease

  Up to 24 months

• Time to Response

  Up to 24 months

Study Arms (2)

AXIN1 Cohort

EXPERIMENTAL

Participants will receive REC-4881 12mg PO dosed QD

Drug: REC-4881

APC Cohort

EXPERIMENTAL

Participants will receive REC-4881 12mg PO dosed QD

Drug: REC-4881

Interventions

REC-4881 DRUG

REC-4881 4mg capsules

APC Cohort; AXIN1 Cohort

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Recursion Pharmaceuticals Inc.: lead

Study Sites (13)

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Eastern Connecticut Hematology & Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Medical Oncology Hematology Consultants

Newark, Delaware, 19713, United States

Location

Cancer Specialists of North Florida

Fleming Island, Florida, 32003, United States

Location

Mission Cancer And Blood

Des Moines, Iowa, 50314, United States

Location

American Oncology Partners of Maryland, PA

Bethesda, Maryland, 20817, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Hunterdon Hematology Oncology

Hillsborough, New Jersey, 08844, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Mary Crowley Cancer Research Centers

Dallas, Texas, 75231, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 23, 2023
• Study Start: January 15, 2024
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)