drugset / Trial / NCT04425070

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

NCT04425070

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Selinexor Other / unclassified 40 mg Oral
Subject Selinexor Other / unclassified 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