Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Adenomatous Polyposis Coli

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA

co-occuring mutation

This is a pathogenic mutation profile of colorectal patients specifically in 5 genes, i.e. APC, TP53, PIK3CA, KRAS, and MLH1. Single nucleotide variants identified were synchronized with patients' characteristics.

Patogenic Mutation in 5 Genes

Genomic Landscape of APC, KRAS, TP53, PIK3CA, and MLH1 in Colorectal

grade, stage, lymphovascular invasion, tumor location

Dr Cipto Mangunkusumo General Hospital

Principal Investigator - Staff of Digestive Division - General Surgery Department

Symptoms and General Pathology

Rare Diseases

Neoplasm Metastasis

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patogenic Mutation in 5 Genes	NCT04976439	Colorectal Canc... APC Gene Mutati... TP53 Gene Mutat... PIK3CA Gene Mut... KRAS Mutation-R... MLH1 Gene Mutat...	co-occuring mut...	18 Years -	Dr Cipto Mangunkusumo General Hospital
Patogenic Mutation in 5 Genes	NCT04976439	Colorectal Canc... APC Gene Mutati... TP53 Gene Mutat... PIK3CA Gene Mut... KRAS Mutation-R... MLH1 Gene Mutat...	co-occuring mut...	18 Years -	Dr Cipto Mangunkusumo General Hospital
A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation	NCT06005974	AXIN1 Gene Muta... APC Gene Mutati... Solid Tumor	REC-4881	55 Years -	Recursion Pharmaceuticals Inc.
Patogenic Mutation in 5 Genes	NCT04976439	Colorectal Canc... APC Gene Mutati... TP53 Gene Mutat... PIK3CA Gene Mut... KRAS Mutation-R... MLH1 Gene Mutat...	co-occuring mut...	18 Years -	Dr Cipto Mangunkusumo General Hospital

Spots Global Cancer Trial Database for apc gene mutation