Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614751
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
A PARG Inhibitor DAT-2645 Monotherapy in Patients with AdvancedMetastatic Solid Tumors Harboring BRCA12 Loss of Function Alterations Andor Other Defects in the DDR Pathway
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of DAT-2645 in Patients with AdvancedMetastatic Solid Tumors Harboring BRCA12 Loss of Function Alterations Andor Other Defects in the DNA Damage Repair Pathway
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to evaluate the safety tolerability PK PD and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advancedmetastatic solid tumors harboring BRCA12 loss of function alterations andor other defects in the DNA damage repair DDR pathway
Detailed Description:
This the the FIH trial of PARG inhibitor DAT-2645This study will include Part 1 dose escalation study and Part 2 dose expansion study Eligible patients will be enrolled into Part 1 and Part 2
In Part 1 6 dose cohorts will be set and definte MTDRDE In Part 2 Dose optimization will be conducted firstly to definite RP2D dose expansion will be conducted in another 2 cohorts to evaluate the efficacy
In Part 1 6 dose cohorts will be set and definte MTDRDE In Part 2 Dose optimization will be conducted firstly to definite RP2D dose expansion will be conducted in another 2 cohorts to evaluate the efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None