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

• Sponsor: Recursion Pharmaceuticals Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06005974
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 39

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
AXIN1 Gene Mutation; APC Gene Mutation; Solid Tumor	Drug: REC-4881	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• 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.Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2027
• Anticipated Study Completion Date: Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AXIN1 Cohort Participants will receive REC-4881 12mg PO dosed QD	Drug: REC-4881; REC-4881 4mg capsules
Experimental: APC Cohort Participants will receive REC-4881 12mg PO dosed QD	Drug: REC-4881; REC-4881 4mg capsules

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment emergent adverse events (AEs) [Assessed from time of ICF signature through up to 24 months of study treatment]

   Safety and tolerability

2. Evaluate the Objective Response Rate (ORR) of REC-4881 using RECIST 1.1 criteria [Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months]

   Efficacy

Secondary Outcome Measures

1. Maximum (peak) plasma drug concentration (Cmax) [Assessed pre-dose and at multiple timepoints up to 24 months]

   Efficacy

2. Time to reach maximum (peak) plasma concentration (Tmax) [Assessed pre-dose and at multiple timepoints up to 24 months]

   Efficacy

3. Area under the plasma concentration-time curve (AUC) [Assessed pre-dose and at multiple timepoints up to 24 months]

   Efficacy

4. Duration of Response (DOR) and Time to Response (TTR) [Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months]

   Efficacy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Recursion Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Recursion Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT06005974
• Other Study ID Numbers: REC-4881-221
• First Posted: Aug 23, 2023
• Last Update Posted: Aug 23, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Recursion Pharmaceuticals Inc.: AXIN1; APC; Locally advanced or metastatic; Solid tumor
• Additional relevant MeSH terms: Adenomatous Polyposis Coli

Study Results

No Results Posted as of Aug 23, 2023