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

NCT ID: NCT06005974

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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AXIN1 Gene Mutation APC Gene Mutation Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AXIN1 Cohort

Participants will receive REC-4881 12mg PO dosed QD

Group Type EXPERIMENTAL

REC-4881

Intervention Type DRUG

REC-4881 4mg capsules

APC Cohort

Participants will receive REC-4881 12mg PO dosed QD

Group Type EXPERIMENTAL

REC-4881

Intervention Type DRUG

REC-4881 4mg capsules

Interventions

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REC-4881

REC-4881 4mg capsules

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Recursion Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sharp Memorial Hospital

San Diego, California, United States

Site Status

Sansum Clinic

Santa Barbara, California, United States

Site Status

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

Eastern Connecticut Hematology & Oncology Associates

Norwich, Connecticut, United States

Site Status

Medical Oncology Hematology Consultants

Newark, Delaware, United States

Site Status

Cancer Specialists of North Florida

Fleming Island, Florida, United States

Site Status

Mission Cancer And Blood

Des Moines, Iowa, United States

Site Status

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States

Site Status

Saint Luke's Hospital

Kansas City, Missouri, United States

Site Status

Hunterdon Hematology Oncology

Hillsborough, New Jersey, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Mary Crowley Cancer Research Centers

Dallas, Texas, United States

Site Status

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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REC-4881-221

Identifier Type: -

Identifier Source: org_study_id