Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078800
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2023-09-27
Brief Title:
A Study of YL-17231 in Patients With Advanced Solid Tumors
Sponsor:
Shanghai YingLi Pharmaceutical Co Ltd
Organization:
Shanghai YingLi Pharmaceutical Co Ltd
Study Overview
Official Title:
Phase I Clinical Study on the Safety Tolerance Pharmacokinetics and Efficacy of Pan-KRAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors With KRAS Mutation
Status:
RECRUITING
Status Verified Date:
2023-10
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 phase 1 open label multicenter study to evaluate the maximum tolerance safety tolerance and PK of oral YL-17231 in patients with advanced solid tumors with KRAS mutation so as to confirm the recommended phase 2 dose of YL-17231 and obtain the preliminary efficacy information of patients with advanced solid tumors with KRAS mutation
Detailed Description:
The study will be conducted in China to provide safety efficacy and PK data A dose escalation part 1 will be conducted to determine the MTD DLTs and part 2 will confirm the safetytolerability of the recommended Phase 2 dose RP2D of YL-17231 given twice daily in patients with advanced solid tumors to obtain preliminary efficacy information PK samplings at single dose stage Day 1 and at steady-state conditions Cycle 1 Day 14 will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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