Clinical Trial

A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors

Active, Not Recruiting Phase 1/2
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Record status
This record was last updated August 7, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 36 amendments
This ClinicalTrials.gov record has been amended 36 times since 2018-07-27; most recent amendment 2025-08-04.
Status change: Recruiting → Active, Not Recruiting 2025-08-04
Status change: Not Yet Recruiting → Recruiting 2018-12-05
Trial Details
NCT Number NCT03611868
Lead Sponsor Ascentage Pharma Group Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma, Uveal Melanoma, P53 Mutation, MDM2 Gene Mutation, Cutaneous Melanoma, Mucosal Melanoma, Malignant Peripheral Nerve Sheath Tumors (MPNST)
Enrollment 230 participants
Start Date 2018-08-29
Primary Completion 2025-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-07