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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06005974

Enrollment

Registered

2023-08-23

Start date

2024-01-15

Completion date

2025-02-24

Last updated

2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

APC Gene Mutation, AXIN1 Gene Mutation, Solid Tumor

Keywords

AXIN1, APC, Locally advanced or metastatic, Solid tumor

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.

Interventions

DRUGREC-4881

REC-4881 4mg capsules

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Disease Control Rate	Up to 24 months
Duration of Stable Disease	Up to 24 months
Time to Response	Up to 24 months
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026