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Trial Title:
A Study of REC-4881 in Participants with Cancers Which Have an AXIN1 or APC Mutation
NCT ID:
NCT06005974
Condition:
AXIN1 Gene Mutation
APC Gene Mutation
Solid Tumor
Conditions: Official terms:
Adenomatous Polyposis Coli
Conditions: Keywords:
AXIN1
APC
Locally advanced or metastatic
Solid tumor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for
the duration of the study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
REC-4881
Description:
REC-4881 4mg capsules
Arm group label:
APC Cohort
Arm group label:
AXIN1 Cohort
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
55 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Eastern Connecticut Hematology & Oncology Associates
Address:
City:
Norwich
Zip:
06360
Country:
United States
Status:
Recruiting
Contact:
Email:
trials@tempus.com
Facility:
Name:
Cancer Specialists of North Florida
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Status:
Recruiting
Contact:
Email:
trials@tempus.com
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Recruiting
Contact:
Email:
trials@tempus.com
Start date:
January 15, 2024
Completion date:
January 2027
Lead sponsor:
Agency:
Recursion Pharmaceuticals Inc.
Agency class:
Industry
Source:
Recursion Pharmaceuticals Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06005974
