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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06005974
Recruitment Status : Recruiting
First Posted : August 23, 2023
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
Recursion Pharmaceuticals Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Actual Study Start Date : January 15, 2024
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. To evaluate the safety and tolerability of REC-4881 [ Time Frame: Assessed from time of ICF signature through up to 24 months of study treatment ]
    Assessment of dose limiting toxicities [(DLTs) Safety Assessment Period only]; Treatment emergent adverse events; Serious adverse events; Treatment discontinuation and dose modification due to toxicity

  2. To evaluate the preliminary anti-tumor activity of REC-4881 as measured by Objective Response Rate (ORR) [ Time Frame: Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, a maximum of 24 months ]
    ORR according to standard RECIST 1.1 criteria


Secondary Outcome Measures :
  1. To characterize the PK of REC-4881 [ Time Frame: Assessed pre-dose and at multiple timepoints up to 24 months ]
    Plasma PK parameters, as appropriate, including but not limited to Cmax, Tmax, Ctrough and AUC

  2. To assess the anti-tumor activity of REC-4881 as measured by to other efficacy endpoints [ Time Frame: Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months ]
    DCR according to standard RECIST 1.1; Duration of response (DOR), Duration of SD, and TTR


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06005974


Contacts
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Contact: Recursion Pharmacueticals 385-374-1724 clinicaltrials@recursionpharma.com

Locations
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Sponsors and Collaborators
Recursion Pharmaceuticals Inc.
More Information
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Responsible Party: Recursion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT06005974    
Other Study ID Numbers: REC-4881-221
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: February 6, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Adenomatous Polyposis Coli
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn