Ignite Creation Date:
2024-05-06 @ 9:13 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02935907
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2016-10-13
Brief Title:
APG-115 in Patients With Advanced Solid Tumors or Lymphomas
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-115 in Patients With Advanced Solid Tumors or Lymphomas
Status:
COMPLETED
Status Verified Date:
2022-07
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:
APG-115
Brief Summary:
APG-115 is a novel orally active small-molecule mouse double minute 2 homolog MDM2 inhibitor Mechanistically APG-115 increases p53 and p21 overexpression activates p53 - mediated apoptosis in tumor cells retaining wild-type p53 APG-115 has shown strong dose- and schedule-dependent antitumor activities in multiple human cancer xenograft and a patient derived xenograft PDX models The preclinical data generated from APG-115 suggest that it 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-115 is intended for the treatment of patients with advanced solid tumors and lymphomas 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?:
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