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The trial is taking place at:
S

Sanford Health | Clinical Research Department

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

R

Recursion Pharmaceuticals

Status and phase

Enrolling
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)

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

Trial contacts and locations

52

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Central trial contact

Recursion Pharmacueticals

Data sourced from clinicaltrials.gov

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