APG-115 in Patients With Advanced Solid Tumors or Lymphomas
Status:
Completed
Trial end date:
2019-06-28
Target enrollment:
Participant gender:
Summary
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.