At a glance
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A Phase IB Study of Safety, Efficacy and Pharmacokinetic of Intravenously Administered Pelcitoclax (APG-1252) in Patients With Advanced Neuroendocrine Tumor
In Brief
A Phase 1 clinical trial evaluating Pelcitoclax for Neuroendocrine Tumors. Terminated early, enrolled 2 participants across 3 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Multiple dose cohorts, 30 minute IV infusion, once a week, 28 days as a cycle