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 (TOUCH)

Antengene

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Peripheral T-cell Lymphoma; NK/T-cell Lymphoma

Treatments: Combination Product: GEMOX [gemcitabine+oxaliplatin]; Combination Product: ICE [ifosfamide+carboplatin+etoposide]; Combination Product: Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04425070

ATG-010-T/NK-001

Details and patient eligibility

About

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.

Full description

This trial is an open-label, multi-center Phase Ib clinical study that will evaluate ATG-010 combined with chemotherapy regimen selected by investigators (ICE regimen ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin; Tislelizumab) sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in R/R PTCL and NK/T-cell lymphoma patients. 97 patients are planned to be enrolled.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient is willing to provide written ICF.
2. Age≥ 18 years.
3. R/R PTCL and NK/T-cell lymphoma as confirmed by histological methods according to WHO classification of tumors of lymphoid tissues 2016.
4. Previously received at least one or more standard regimens including anthracycline.
5. Recurrence or the recurrence disease after the last treatment completed.
6. At least one measurable disease per modified efficacy assessment criteria (Cheson 2014).
7. ECOG PS 0 or 1.
8. Any toxicity caused by previously anti-tumor therapy must recovered to ≤ Grade 1 (NCI-CTCAE v5.0) with exception of hearing loss, alopecia, and pigmentation.
9. Expected life time longer than 3 months.

Exclusion criteria

1. Current have disease or history of central nervous system lymphoma.
2. HBV-DNA positive, or HCV-RNA positive.
3. Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
4. Received major surgery within 4 weeks of first dose of study drug
5. Known received SINE, including ATG-010.
6. Unable to swallow the tablets, suffers from malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with ATG-010 absorption.
7. Known allergy to ATG-010, or ICE, or GEMOX.
8. A woman who is pregnant or nursing.
9. The investigator considerations on patient's complications or other conditions may affect protocol compliance or may be inappropriate for participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 3 patient groups

ATG-010 + ICE

Experimental group

Description:

ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11

Treatment:

Combination Product: ICE [ifosfamide+carboplatin+etoposide]

ATG-010 + GEMOX

Experimental group

Description:

ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9

Treatment:

Combination Product: GEMOX [gemcitabine+oxaliplatin]

ATG-010 + Tislelizumab

Experimental group

Description:

ATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle

Treatment:

Combination Product: Tislelizumab