NCT04893759

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

A Phase IB Study of Safety, Efficacy and Pharmacokinetic of Intravenously Administered Pelcitoclax (APG-1252) in Patients With Advanced Neuroendocrine Tumor

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Pelcitoclax	Multiple dose cohorts, 30 minute IV infusion, once a week, 28 days as a cycle

Timeline

• Start date: 2022-01-06
• Primary completion: 2022-09-14
• Completion: 2022-09-14
• First posted: 2021-05-19
• Last updated: 2025-04-17

Locations

3 sites across 1 country: China