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Clinical Trial Summary

The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-1252 single agent and in combination with other therapeutic agent in patients with NHL.


Clinical Trial Description

This is an open-label, multi-center Phase Ib/II study of safety, PK, PD and efficacy of APG-1252 as a single agent in relapsed/refractory NHL or in combination with chidamide in relapsed/refractory peripheral T cell lymphomas (PTCL) patients. The primary objective is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT), the maximum tolerated dose (MTD) and the recommended dose (RP2D) of APG-1252 monotherapy or in combination with chidamide in relapsed/refractory PTCL patients. This study consists of two parts: The first part is the APG-1252 single agent cohort, including dose escalation phase with a standard 3+3 design and dose expansion phase with 6-15 patients at MTD dose level. The second part is the APG-1252 plus chidamide, including dose escalation phase with a standard 3+3 design and dose expansion phase with 9-12 patients at MTD dose level. Patients will be treated in 28-day cycles. APG-1252 will be administered via intravenous infusion for 30 minutes weekly (Day 1, 8, 15, 22). Chidamide will be administered 30mg orally BIW. All subjects will continue to receive treatment until disease progression, unacceptable toxicities, or other treatment discontinuation criteria defined by the protocol. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05186012
Study type Interventional
Source Ascentage Pharma Group Inc.
Contact Weili Zhao, MD.
Phone 13512112076
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date March 2022
Completion date March 2024