A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma

Phase 1/2 Terminated 56 enrolled Antengene Corporation

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which will be chosen by investigators (ICE \[ifosfamide+carboplatin+etoposide\] or GEMOX \[gemcitabine+oxaliplatin\] or Tislelizumab), after treatments of 2 to 6 cycles transferring to ATG-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary efficacy of ATG-010 in R/R PTCL and NK/T-cell lymphoma patients.

Timeline

Start: 2020-08-18
Primary completion: 2025-12-30
Completion: 2025-12-30

Outcome

Outcome not reported

Stopped (Business): “Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study”

Publications

Liu C, Li D, Gao Y, Zhang W, Guo Z, Zhao J, Huang H, Tao R. Selinexor plus tislelizumab in patients with relapsed/refractory NK/T-cell lymphoma after failure of PD-1 blockade: the phase 1b TOUCH trial. Oncologist. 2026 Jul 11:oyag266. doi: 10.1093/oncolo/oyag266. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ATG-010	Unknown	40 mg	Oral
Subject	ATG-010	Unknown	60 mg	Oral
Background	2-MERCAPTOETHANESULFONIC ACID	Small molecule	5000 mg/m2	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Etoposide	Small molecule	100 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Ifosfamide	Small molecule	5000 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Background	Tislelizumab	Monoclonal antibody	200 mg	Intravenous