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Based on the adjustment of clinical research and development strategy,sponsor decided to terminate the study
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG-010 + ICE | Experimental | ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11 |
|
| ATG-010 + GEMOX | Experimental | ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9 |
|
| ATG-010 + Tislelizumab | Experimental | ATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICE [ifosfamide+carboplatin+etoposide] | Combination Product | • Combined with ICE chemotherapy regimen:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR) | Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented. | 18 months |
| Disease control rate (DCR) | Proportion of patients who achieve CR, PR, or SD for a minimum of 4 weeks, following the first dose of study drug (i.e., CR+PR+SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yang Yu, MD | Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Hefei | Anhui | 230031 | China | ||
| Beijing Tongren Hospital.CMU |
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ATG-010 + ICE ATG-010 + GEMOX ATG-010 + Tislelizumab
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|
| GEMOX [gemcitabine+oxaliplatin] | Combination Product | • Combined with GEMOX chemotherapy regimen:
|
|
| 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 |
|
| 4 weeks to 18 months |
| Progression-free survival (PFS) | Duration of time from the first dose of study drug until progression or death due to any cause | 18 months |
| Overall Survival (OS) | Duration of time from the first dose of study drug until death due to any cause | 18 months |
| Beijing |
| Beijing Municipality |
| 100005 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Chongqing University Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Guangxi Medical University Cancer Hospital | Nanning | Guangxi | 530021 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| Tianjin Medical Universisity Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007053 | Ice |
| C508870 | gemcitabine-oxaliplatin regimen |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
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