APG-1387 in Patients With Advanced Solid Tumors or Hematologic Malignancies
Status:
Recruiting
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
APG-1387 is a potent, bivalent small-molecule Inhibitor of Apoptosis Protein (IAP)
antagonist. APG-1387 has shown strong dose- and schedule-dependent antitumor activities in
multiple human cancer xenograft models, APG-1387 also demonstrates its synergistic effect in
combination with immune checkpoint inhibitor anti-PD-1 antibody, and such a combinatory
effect was further enhanced by chemotherapeutic agent. A total of 35 patients with advanced
solid tumors or lymphomas have been treated with APG-1387 in two Phase I dose-escalation
studies in Australia and in China. Ten dose levels have been tested ranging from 0.3 mg to 45
mg in these two studies. Based on the preliminary results, APG-1387 is well-tolerated at the
dose levels evaluated to date. APG-1387 is intended for the treatment of patients with
advanced solid tumors and hematologic malignancies. After establishing the maximum tolerated
dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several
Ib /II studies will be implemented accordingly to further access the antitumor effects of
APG-1387 in combination with either pembrolizumab or the chemotherapeutic agents.