A Study of APG-1252 in Patients With SCLC or Other Solid Tumors
Status:
Completed
Trial end date:
2020-07-17
Target enrollment:
Participant gender:
Summary
APG-1252 is a highly potent Bcl-2 family protein inhibitor, a promising drug candidate which
shown high binding affinities to Bcl-2, Bcl-xL and Bcl-w. The preclinical studies have shown
that APG-1252 alone achieves complete and persistent tumor regression in multiple tumor
xenograft models with a twice weekly or weekly dose-schedule, including SCLC, colon, breast
and acute lymphocytic leukemia (ALL) cancer xenografts; achieves strong synergy with the
chemotherapeutic agents, indicating that APG-1252 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-1252 is intended for the treatment of patients with SCLC or other solid
tumors.
This is a multi-center, open-label, dose escalation Phase I study to determine the MTD and
DLTs of intravenously administered APG-1252. After dose escalation to 240mg twice weekly, 2
dose cohorts two different dosing schedules including weekly and twice weekly will be
assessed to evaluate for safety, tolerability, pharmacokinetics (PK) and preliminary
anti-tumor efficacy. Treatment with APG-1252 will be administered to 30-60 patients at
approximately 2 investigational sites in US.