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 | Terminated Phase 1

• 1 other identifier: ATG-010-T/NK-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• AEs/SAEs

  Toxicity will be graded according to the NCI CTCAE, Version 5.0.

  18 months

• Overall Response Rate (ORR)

  To determine the overall response rate according to Chenson 2014.

  18 months

Secondary Outcomes (4)

• Duration of response (DOR)

  18 months

• Disease control rate (DCR)

  4 weeks to 18 months

• Progression-free survival (PFS)

  18 months

• Overall Survival (OS)

  18 months

Study Arms (3)

ATG-010 + ICE

EXPERIMENTAL

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

Combination Product: ICE [ifosfamide+carboplatin+etoposide]

ATG-010 + GEMOX

EXPERIMENTAL

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

Combination Product: GEMOX [gemcitabine+oxaliplatin]

ATG-010 + Tislelizumab

EXPERIMENTAL

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

Combination Product: Tislelizumab

Interventions

ICE [ifosfamide+carboplatin+etoposide] COMBINATION_PRODUCT

• Combined with ICE chemotherapy regimen: * Ifosfamide: 5 g/m2, continuous intravenous (iv) infusion (mesna 5 g/m2 synchronously iv infusion for rescue), on Day 2; * Carboplatin: with concentration-area under time curve (AUC)=5 (highest concentration to 800 mg), iv infusion, on Day 2; * Etoposide l00 mg/m2, iv infusion, on Days 1-3; * ATG-010 60 mg/once, oral, on Days 4 and 11. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).

ATG-010 + ICE

GEMOX [gemcitabine+oxaliplatin] COMBINATION_PRODUCT

• Combined with GEMOX chemotherapy regimen: * Gemcitabine 1000 mg/m2, iv infusion, on Days 1 and 8; * Oxaliplatin 130 mg/m2, iv infusion, on Day 1; * ATG-010 60 mg/once, oral, on Days 2 and 9. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).

ATG-010 + GEMOX

Tislelizumab COMBINATION_PRODUCT

Tislelizumab will be administered intravenously at a fixed dose of 2 0 0 mg every 3 weeks on Day 1 of each cycle

ATG-010 + Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is willing to provide written ICF.
• Age≥ 18 years.
• R/R PTCL and NK/T-cell lymphoma as confirmed by histological methods according to WHO classification of tumors of lymphoid tissues 2016.
• Previously received at least one or more standard regimens including anthracycline.
• Recurrence or the recurrence disease after the last treatment completed.
• At least one measurable disease per modified efficacy assessment criteria (Cheson 2014).
• ECOG PS 0 or 1.
• 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.
• Expected life time longer than 3 months.

You may not qualify if:

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

Sponsors & Collaborators

• Antengene Corporation: lead

Study Sites (13)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, China

Location

Beijing Tongren Hospital.CMU

Beijing, Beijing Municipality, 100005, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210000, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Tianjin Medical Universisity Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell

Interventions

Ice; gemcitabine-oxaliplatin regimen; tislelizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Yang Yu, MD

  Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: ATG-010 + ICE ATG-010 + GEMOX ATG-010 + Tislelizumab

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 11, 2020
• Study Start: August 18, 2020
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

CN (13)