A Phase 2, Open Label Study of REC-4881 in Participants With Unresectable Locally Advanced or Metastatic Cancer With AXIN1 or APC Mutation
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 18
- Locations
- 13
- Primary Endpoint
- Number of Participants with Dose Limiting Toxicities
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Arms & Interventions
AXIN1 Cohort
Participants will receive REC-4881 12mg PO dosed QD
Intervention: REC-4881 (Drug)
APC Cohort
Participants will receive REC-4881 12mg PO dosed QD
Intervention: REC-4881 (Drug)
Outcomes
Primary Outcomes
Number of Participants with Dose Limiting Toxicities
Time Frame: Up to 24 months
Objective Response Rate
Time Frame: Up to 24 months
Secondary Outcomes
- Area Under the Plasma Concentration-time Curve (AUC) of REC-4881(pre-dose and up to 24 months)
- Disease Control Rate(Up to 24 months)
- Duration of response(Up to 24 months)
- Duration of Stable Disease(Up to 24 months)
- Time to Response(Up to 24 months)