Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06005974
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-08-10
Brief Title:
A Study of REC-4881 in Participants with Cancers Which Have an AXIN1 or APC Mutation
Sponsor:
Recursion Pharmaceuticals Inc
Organization:
Recursion Pharmaceuticals Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None