CLINICAL TRIALS PROFILE FOR APG-115
✉ Email this page to a colleague
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). |
| NCT03781986 ↗ | APG-115 in Salivary Gland Cancer Trial | Recruiting | University of Michigan Rogel Cancer Center | 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). |
| NCT04275518 ↗ | A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS. | Recruiting | Suzhou Yasheng Pharmaceutical Co., Ltd. | Phase 1 | Acute myeloid leukemia is a malignant disorder characterized by the rapid, uncontrolled proliferation of malignant clonal hematopoietic stem cells that accumulate as immature, undifferentiated cells (blasts) in the bone marrow and circulation. APG-115 is a potent and orally active small-molecule MDM2 inhibitor, it binds to MDM2 protein and shows potent cell growth inhibitory activity in vitro with low nanomolar potencies in a subset of human cancer cell lines. APG-115 has demonstrated its strong antitumor activities with either daily or less frequent dosing-schedules in the acute leukemia xenograft models. This is a phase 1b, open-label, three-stages study that will initially evaluate the safety and PK/PD profile of APG-115 as a single agent, followed by a combination of APG-115 + azacytidine or cytarabine in R/R AML or MDS subjects. Patients will continue treatment for maximally 6 cycles or until progression of disease or unacceptable toxicity is observed or administrative discontinuation whichever occurs first. Patients who continue to be benefit after 6 cycles' treatment will receive additional cycles of treatment until progression of disease, unacceptable toxicity is observed or administrative discontinuation. (As long as it is proven safe). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for APG-115
Condition Name
Clinical Trial Locations for APG-115
Trials by Country
Clinical Trial Progress for APG-115
Clinical Trial Phase
Clinical Trial Sponsors for APG-115
Sponsor Name
