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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06005974
• Other study ID #: REC-4881-221
• Status: Recruiting
• Phase: Phase 2
• Start date: January 15, 2024
• Est. completion date: January 2027

Study information

• Verified date: February 2024
• Source: Recursion Pharmaceuticals Inc.
• Contact: Recursion Pharmacueticals
• Phone: 385-374-1724
• Email: clinicaltrials[@]recursionpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Solid Tumor

Intervention

Drug:
• REC-4881
REC-4881 4mg capsules

Locations

Country	Name	City	State
United States	ThedaCare	Appleton	Wisconsin
United States	University Cancer & Blood Center	Athens	Georgia
United States	Our Lady of the Lake	Baton Rouge	Louisiana
United States	New Jersey Cancer Care	Belleville	New Jersey
United States	PeaceHealth	Bellingham	Washington
United States	Aultman Medical Group	Canton	Ohio
United States	TOI Clinical Research	Cerritos	California
United States	TriHealth Cancer Institute	Cincinnati	Ohio
United States	HOACNY	East Syracuse	New York
United States	Englewood Health	Englewood	New Jersey
United States	Southcoast Centers for Cancer Care	Fairhaven	Massachusetts
United States	Sanford Health - Fargo	Fargo	North Dakota
United States	Summit Medical Group	Florham Park	New Jersey
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Hematology Oncology Associates of Fredericksburg	Fredericksburg	Virginia
United States	Providence Medical Foundation (Fullerton)	Fullerton	California
United States	The Center for Cancer and Blood Disorders	Germantown	Maryland
United States	PCSRI - Gettysburg	Gettysburg	Pennsylvania
United States	Bon Secours (Greenville) - St. Francis Cancer Center	Greenville	South Carolina
United States	Hope and Healing Cancer Services	Hinsdale	Illinois
United States	Oncology Consultants	Houston	Texas
United States	Community Health Network	Indianapolis	Indiana
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Gundersen Health System	La Crosse	Wisconsin
United States	TOI Florida	Lakeland	Florida
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	OptumCare Cancer Care	Las Vegas	Nevada
United States	MemorialCare	Long Beach	California
United States	Cancer and Blood Research Center	Los Alamitos	California
United States	Eastern Connecticut Hematology & Oncology Associates	Norwich	Connecticut
United States	Ssm Health Care Of Oklahoma- Inc.	Oklahoma City	Oklahoma
United States	Vista Oncology	Olympia	Washington
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	Northwest Oncology & Hematology	Rolling Meadows	Illinois
United States	Mosaic Life Care	Saint Joseph	Missouri
United States	Oregon Oncology Specialists	Salem	Oregon
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Sharp HealthCare	San Diego	California
United States	Ridley-Tree Cancer Center	Santa Barbara	California
United States	Providence Medical Foundation (Santa Rosa)	Santa Rosa	California
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Sanford Health	Sioux Falls	South Dakota
United States	Cancer Care Northwest	Spokane	Washington
United States	Highlands Oncology	Springdale	Arkansas
United States	Lumi Research	Sugar Land	Texas
United States	Northwest Medical Specialties	Tacoma	Washington
United States	The Toledo Clinic	Toledo	Ohio
United States	Oklahoma Cancer Specialists and Research Institute	Tulsa	Oklahoma
United States	Cancer Care Associates of York	York	Pennsylvania
United States	Yuma Regional Medical Center	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Recursion Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of REC-4881	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	Assessed from time of ICF signature through up to 24 months of study treatment
Primary	To evaluate the preliminary anti-tumor activity of REC-4881 as measured by Objective Response Rate (ORR)	ORR according to standard RECIST 1.1 criteria	Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, a maximum of 24 months
Secondary	To characterize the PK of REC-4881	Plasma PK parameters, as appropriate, including but not limited to Cmax, Tmax, Ctrough and AUC	Assessed pre-dose and at multiple timepoints up to 24 months
Secondary	To assess the anti-tumor activity of REC-4881 as measured by to other efficacy endpoints	DCR according to standard RECIST 1.1; Duration of response (DOR), Duration of SD, and TTR	Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months