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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 is an Asian multi-regional clinical trial (MRCT) in which ATG-008 will be administered orally to hepatitis B positive (HBV+) HCC subjects who have received at least one prior line of systemic therapy. It is designed as an open-label phase 2 trial evaluating the pharmacokinetics (PK), safety, tolerability and efficacy of oral ATG-008 administered daily until the radiologic disease progression (according to RECIST 1.1) or intolerable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG-008 | Experimental | To enroll approximately 40 hepatitis B virus (HBV) positive, unresectable HCC subjects who have previously received at least one prior line of systemic therapy. Among which, approximately 20 subjects will receive oral ATG-008 at an initial dose of 45 mg, once daily (QD) and another approximately 20 subjects will receive oral ATG-008 at an initial dose of 20 mg, twice daily (BID). The pharmacokinetic (PK) samples will be collected from 10 subjects each in the two dose groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATG-008 | Drug | Approximately 20 subjects will receive oral ATG-008 at an initial dose of 45 mg/QD and another 20 subjects will receive oral ATG-008 at an initial dose of 20mg/BID for 28 days each cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak Plasma Concentration (Cmax) | Day 1 - Day 15 |
| AUC | Area under the plasma concentration versus time curve (AUC) | Day 1 - Day 15 |
| The incidence of treatment emergent adverse events (TEAEs) & SAE assessed by CTCAE v4.03 | The treatment emergent adverse events (TEAEs) & SAE case No. in total subject No. | 365 DAYS |
| ORR | Percentage of subjects with PR, or CR | 365 DAYS |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Kaplan-Meier estimate of Overall Survival | 365 DAYS |
| TTP | The time from the first dose date until disease progression | 365 DAYS |
| Measure | Description | Time Frame |
|---|---|---|
| Potential biomarkers in plasma and tumor tissues | The changes in potential biomarkers including but not limited to TORC1/TORC2 activity in peripheral blood samples and tumor tissue following treatment with ATG-008 | 365 DAYS |
| Additional metabolites of ATG-008 in plasma and urine |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Xie, PhD | Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Hospital of Haerbin Medical University | Harbin | Heilongjiang | 150000 | China | ||
| China People PLA 81 Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2018 |
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| PFS | The time from the first dose date until disease progression or death from any cause | 365 DAYS |
| DCR | The percentage of subjects with CR, or PR or stable disease (SD) | 365 DAYS |
| DOR | The time from the criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented | 365 DAYS |
| TTR | The time from the first dose date to the first documentation of response of PR or better. | 365 DAYS |
| 6, 9 and 12 month of survival rate | Percentage of patients alive | 365 DAYS |
Additional metabolites of ATG-008 in plasma and urine, and the extent of their urinary excretion/clearance |
| Day 1 - Day 15 |
| Nanjing |
| Jiangsu |
| 210000 |
| China |
| West China Hospital Sichuan University | Chengdu | Sichuan | 610041 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650118 | China |
| The first Hospital of Jilin University | Changchun | China |
| Hunan Province Oncology Hospital | Changsha | China |
| Daping Hospital | Chongqing | China |
| The first hospital of Chongqing medical university | Chongqing | China |
| Xiehe Hospital of Fujian Medical University | Fuzhou | China |
| Nanfang Hospital of Nanfang Medical University | Guangzhou | China |
| The first affiliated Hospital of Zhejiang University | Hangzhou | China |
| Zhejiang Province Oncology Hospital | Hangzhou | China |
| The first affiliated hospital of Anhui medical university | Hefei | China |
| The second affiliated hospital of Anhui medical university | Hefei | China |
| The first affiliated hospital of Guangxi Medical University | Nanning | China |
| Oncology Hospital of Fudan University | Shanghai | China |
| Zhongshan Hospital of Fudan University | Shanghai | China |
| General Hospital of the Northern War Zone of the Chinese People's Liberation Army | Shenyang | China |
| Tangdu Hospital of China PLA fourth medical university | Xi'an | China |
| Dong-A University Hospital | Busan | South Korea |
| Pusan National Univ. Hospital | Busan | South Korea |
| Kyungpook National Univ. Hospital | Daegu | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| China Medical University Hospital | Taichung | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Medical University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Chang Gung Memorial Hospital-Linkuo | Taoyuan | Taiwan |
| Jan 31, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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