Clinical trial · Interventional
A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation
A Phase 2, Open Label Study of REC-4881 in Participants With Unresectable Locally Advanced or Metastatic Cancer With AXIN1 or APC Mutation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated due to sponsor decision. This decision was not related to safety concerns.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| APC Gene Mutation | — | UNRESOLVED | — |
| AXIN1 Gene Mutation | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| REC-4881 | Drug | MEK Inhibitor REC-4881 | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AXIN1 Cohort
- description
- Participants will receive REC-4881 12mg PO dosed QD
- interventionNames
- Drug: REC-4881
- type
- EXPERIMENTAL
- label
- APC Cohort
- description
- Participants will receive REC-4881 12mg PO dosed QD
- interventionNames
- Drug: REC-4881
Primary outcomes (2)
- measure
- Number of Participants with Dose Limiting Toxicities
- timeFrame
- Up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available