Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462183
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-07
Brief Title:
Study of Safety and Efficacy of RGT-61159 in Adults With RelapsedRefractory Adenoid Cystic Carcinoma ACC or Colorectal Carcinoma CRC
Sponsor:
Rgenta Therapeutics Inc
Organization:
Rgenta Therapeutics Inc
Study Overview
Official Title:
A Phase 1a1b First-in-human Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients With RelapsedRefractory Adenoid Cystic Carcinoma ACC or Colorectal Carcinoma CRC
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:
Phase 1 study to evaluate safety tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC
Detailed Description:
This first-in-human Phase 1 multi-center open-label non-randomized study is designed to evaluate safety tolerability and anti-tumor activity of once-daily RGT-61159 in patients with advanced RR ACC or RR CRC for whom standard therapy with proven clinical benefit does not exist is no longer effective or is not appropriate RGT-61159 is an oral small molecule MYB inhibitor
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