Clinical trial NCT06005974: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: AXIN1 Gene Mutation
APC Gene Mutation
Solid Tumor
Keywords: AXIN1
APC
Locally advanced or metastatic
Solid tumor
Lead sponsor: Recursion Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: To evaluate the safety and tolerability of REC-4881
timeFrame: Assessed from time of ICF signature through up to 24 months of study treatment
measure: To evaluate the preliminary anti-tumor activity of REC-4881 as measured by Objective Response Rate (ORR)
timeFrame: Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, a maximum of 24 months
Secondary outcomes:
measure: To characterize the PK of REC-4881
timeFrame: Assessed pre-dose and at multiple timepoints up to 24 months
measure: To assess the anti-tumor activity of REC-4881 as measured by to other efficacy endpoints
timeFrame: Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology Associates
state: Connecticut
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants
state: Delaware
city: Fleming Island
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Des Moines
country: United States
facility: Mission Cancer And Blood
state: Iowa
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland, PA
state: Maryland
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Hillsborough
country: United States
facility: Hunterdon Hematology Oncology
state: New Jersey
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Centers
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
Study officials:
References: