NCT05186012

APG-1252 Monotherapy or in Combination With Other Therapeutic Agent in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma

A Phase Ib/II Study of APG-1252 as a Single Agent or in Combination With Other Therapeutic Agent in Patients With Relapsed and/or Refractory Non-Hodgkin Lymphoma(NHL)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• NHL, Adult

Interventions

Type	Name	Description
DRUG	APG-1252	APG-1252 administered via intravenous infusion for 30 minutes weekly (Day 1, 8, 15, 22).Every 28 days as a cycle.
DRUG	Chidamide	Chidamide 30mg orally BIW. Every 28 days as a cycle.

Timeline

• Start date: 2022-06-14
• Primary completion: 2025-09-01
• Completion: 2026-03-01
• First posted: 2022-01-11
• Last updated: 2024-01-23

Locations

4 sites across 1 country: China