drugset / Trial / NCT04893759

A Study of Pelcitoclax (APG-1252) in Patients With Neuroendocrine Tumors

NCT04893759

Phase 1 Terminated 2 enrolled Ascentage Pharma Group Inc.
NaSingle-groupOpen-labelTreatment

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 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 neuroendocrine tumors. The purpose of the phase 1b study to establish the maximum tolerated dose (MTD), and/or recommended phase 2 dose (RP2D). Preliminary efficacy and pharmacokinetic properties will be aslo evaluated.

Timeline

Start
2022-01-06
Primary completion
2022-09-14
Completion
2022-09-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Pelcitoclax Small molecule Intravenous