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.
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.
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.
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).
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