Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03917043
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2019-03-25
Brief Title:
APG-2449 in Patients With Advanced Solid Tumors
Sponsor:
Ascentage Pharma Group Inc
Organization:
Ascentage Pharma Group Inc
Study Overview
Official Title:
A Phase I Study of the Safety Pharmacokinetic and Pharmacodynamic Properties of Orally Administered APG-2449 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-11
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:
APG-2449 is a novel orally active multi-targeted tyrosine kinase inhibitor which inhibits FAK ALK and ROS1 with nanomolar potencies In preclinical studies APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent In combination treatment APG-2449 enhanced anti-proliferative activities of several chemotherapeutic and targeted agents It is indicated that APG-2449 may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs APG-2449 is intended for the treatment of patients with advanced solid tumors Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose MTD dose-limiting toxicities DLTs andor recommended phase 2 dose RP2D several phase IbII studies will be implemented accordingly
Detailed Description:
None
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