Back to resultsA Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation
Primary Purpose
AXIN1 Gene Mutation, APC Gene Mutation, Solid Tumor
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
REC-4881
Sponsored by
About this trial
This is an interventional treatment trial for AXIN1 Gene Mutation focused on measuring AXIN1, APC, Locally advanced or metastatic, Solid tumor
Eligibility Criteria
Inclusion Criteria: 18 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AXIN1 Cohort
APC Cohort
Arm Description
Participants will receive REC-4881 12mg PO dosed QD
Participants will receive REC-4881 12mg PO dosed QD
Outcomes
Primary Outcome Measures
Incidence of treatment emergent adverse events (AEs)
Safety and tolerability
Evaluate the Objective Response Rate (ORR) of REC-4881 using RECIST 1.1 criteria
Efficacy
Secondary Outcome Measures
Maximum (peak) plasma drug concentration (Cmax)
Efficacy
Time to reach maximum (peak) plasma concentration (Tmax)
Efficacy
Area under the plasma concentration-time curve (AUC)
Efficacy
Duration of Response (DOR) and Time to Response (TTR)
Efficacy
Full Information
NCT ID
NCT06005974
First Posted
August 10, 2023
Last Updated
August 21, 2023
Sponsor
Recursion Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06005974
Brief Title
A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation
Official Title
A Phase 2, Open Label Study of REC-4881 in Participants With Unresectable Locally Advanced or Metastatic Cancer With AXIN1 or APC Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Recursion Pharmaceuticals Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AXIN1 Gene Mutation, APC Gene Mutation, Solid Tumor
Keywords
AXIN1, APC, Locally advanced or metastatic, Solid tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AXIN1 Cohort
Arm Type
Experimental
Arm Description
Participants will receive REC-4881 12mg PO dosed QD
Arm Title
APC Cohort
Arm Type
Experimental
Arm Description
Participants will receive REC-4881 12mg PO dosed QD
Intervention Type
Drug
Intervention Name(s)
REC-4881
Intervention Description
REC-4881 4mg capsules
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events (AEs)
Description
Safety and tolerability
Time Frame
Assessed from time of ICF signature through up to 24 months of study treatment
Title
Evaluate the Objective Response Rate (ORR) of REC-4881 using RECIST 1.1 criteria
Description
Efficacy
Time Frame
Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months
Secondary Outcome Measure Information:
Title
Maximum (peak) plasma drug concentration (Cmax)
Description
Efficacy
Time Frame
Assessed pre-dose and at multiple timepoints up to 24 months
Title
Time to reach maximum (peak) plasma concentration (Tmax)
Description
Efficacy
Time Frame
Assessed pre-dose and at multiple timepoints up to 24 months
Title
Area under the plasma concentration-time curve (AUC)
Description
Efficacy
Time Frame
Assessed pre-dose and at multiple timepoints up to 24 months
Title
Duration of Response (DOR) and Time to Response (TTR)
Description
Efficacy
Time Frame
Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Recursion Pharmacueticals
Phone
385-374-1724
Email
clinicaltrials@recursionpharma.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation
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