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

Recursion Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Solid Tumor; APC Gene Mutation; AXIN1 Gene Mutation

Treatments: Drug: REC-4881

Study type: Interventional

Funder types: Industry

Identifiers

NCT06005974

REC-4881-221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

AXIN1 Cohort

Experimental group

Description:

Participants will receive REC-4881 12mg PO dosed QD

Treatment:

Drug: REC-4881

APC Cohort

Experimental group

Description:

Participants will receive REC-4881 12mg PO dosed QD

Treatment:

Drug: REC-4881