Ignite Creation Date:
2024-05-06 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03611868
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2018-07-27
Brief Title:
A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors
Sponsor:
Ascentage Pharma Group Inc
Organization:
Ascentage Pharma Group Inc
Study Overview
Official Title:
A Phase IbII Study of APG-115 as a Monotherapy or in Combination With Pembrolizumab in Patients With Unresectable or Metastatic Melanomas or Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This study aims to assess the safety tolerability pharmacokinetics and preliminary efficacy of APG-115 an MDM2 inhibitor either alone or in combination with pembrolizumab a programmed cell death protein-1 PD-1 inhibitor in patients with metastatic melanomas or advanced solid tumors Our hypothesis is that restoration of the immune response concomitant to inhibition of the MDM2 pathway which restores p53 functions may promote cancer cell death leading to effective anticancer therapy
Detailed Description:
This is a phase III study to assess the safety and tolerability of APG-115 alone or in combination with pembrolizumab in patients with unresectable or metastatic melanoma NSCLC solid tumors with ATM mutation liposarcoma urothelial carcinomas and malignant peripheral nerve sheath tumors MPNSTThe hypothesis is that the current therapy may improve ORR progression-free survival and synergistic effect of APG-115 alone or in combination with pembrolizumab in these patients n230 ID NCT03611868
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Keynote MK-3475-B66 | OTHER | Merck and Co | None |