Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Neoplasm Metastasis

Adenomatous Polyposis Coli

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Participants will receive REC-4881 12mg PO dosed QD

REC-4881

Recursion Pharmacueticals

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.

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.

Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.

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

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

ORR according to standard RECIST 1.1 criteria

Plasma PK parameters, as appropriate, including but not limited to Cmax, Tmax, Ctrough and AUC

DCR according to standard RECIST 1.1; Duration of response (DOR), Duration of SD, and TTR

Spots Global Cancer Trial Database for axin1 gene mutation