drugset / Trial / NCT03611868
A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors
Phase 1/2
Active not recruiting
230 enrolled
Ascentage Pharma Group Inc.
Merck Sharp & Dohme LLC · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2018-08-29
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alrizomadlin | Small molecule | 50 mg | Oral |
| Subject | Alrizomadlin | Small molecule | 100 mg | Oral |
| Subject | Alrizomadlin | Small molecule | 150 mg | Oral |
| Subject | Alrizomadlin | Small molecule | 200 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |