Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05787587
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-03-17
Brief Title:
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Sponsor:
IDEAYA Biosciences
Organization:
IDEAYA Biosciences
Study Overview
Official Title:
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The purpose of this study is to characterize the safety tolerability and efficacy of IDE161
Detailed Description:
The purpose of this study is to characterize the safety tolerability including determination of maximum tolerated dose MTD maximum accepted dose MAD recommended doses for expansion RDE andor recommended Phase 2 dose RP2D pharmacokinetics PK pharmacodynamics PD and preliminary anti-tumor activity of IDE161 as a single agent in participants with advanced or metastatic solid tumors harboring BRCA12 loss of function alterations andor other defects in the homologous recombination HR pathway
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