TerminatedPhase 2

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

Stopped: Study was terminated due to sponsor decision. This decision was not related to safety concerns.

United States18 participantsStarted 2024-01-15

Plain-language 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.

Who can participate

Age range55 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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

Exclusion criteria

✕. 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

What they're measuring

Number of Participants with Dose Limiting Toxicities

Timeframe: Up to 24 months

Objective Response Rate

Timeframe: Up to 24 months

Trial details

NCT IDNCT06005974

SponsorRecursion Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-24

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