CLINICAL TRIALS PROFILE FOR APG-115
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Clinical Trials for APG-115
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02935907 ↗ | APG-115 in Patients With Advanced Solid Tumors or Lymphomas | Completed | Ascentage Pharma Group Inc. | Phase 1 | 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), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will be implemented accordingly. |
| NCT03611868 ↗ | A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors | Recruiting | Merck Sharp & Dohme Corp. | Phase 1/Phase 2 | Part 1 is the dose escalation of APG-115 in combination with label dose of pembrolizumab. Part 2 is phase II design of APG-115 at recommended phase 2 dose (RP2D) in combination with pembrolizumab in patients with programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) refractory/relapsed melanoma or NSCLC, lung adenocarcinoma with STK11 mutation, solid tumors with P53 WT and ATM mutation, P53 WT and MDM2 amplification liposarcomas, PD-1/PD-L1 refractory/relapsed urothelial carcinoma without FGFR translocation mutation, and MPNST. |
| NCT03611868 ↗ | A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors | Recruiting | Ascentage Pharma Group Inc. | Phase 1/Phase 2 | Part 1 is the dose escalation of APG-115 in combination with label dose of pembrolizumab. Part 2 is phase II design of APG-115 at recommended phase 2 dose (RP2D) in combination with pembrolizumab in patients with programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) refractory/relapsed melanoma or NSCLC, lung adenocarcinoma with STK11 mutation, solid tumors with P53 WT and ATM mutation, P53 WT and MDM2 amplification liposarcomas, PD-1/PD-L1 refractory/relapsed urothelial carcinoma without FGFR translocation mutation, and MPNST. |
| NCT03781986 ↗ | APG-115 in Salivary Gland Cancer Trial | Recruiting | Ascentage Pharma Group Inc. | Phase 1/Phase 2 | This is a phase I/II trial to evaluate the efficacy of APG-115 +/- Carboplatin for the treatment p53 wild-type malignant salivary gland cancer. Part 1 consisted of 2 arms, arm A (APG-115 monotherapy) and arm B (APG-115 + Carboplatin) and was terminated early. Part 2 is a single arm study (APG-115 monotherapy). |
| NCT03781986 ↗ | APG-115 in Salivary Gland Cancer Trial | Recruiting | University of Michigan | Phase 1/Phase 2 | This is a phase I/II trial to evaluate the efficacy of APG-115 +/- Carboplatin for the treatment p53 wild-type malignant salivary gland cancer. Part 1 consisted of 2 arms, arm A (APG-115 monotherapy) and arm B (APG-115 + Carboplatin) and was terminated early. Part 2 is a single arm study (APG-115 monotherapy). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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