Study Stopped
Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study
Dual TORC1/TORC2 Inhibitor ATG-008 (CC-223) in HBV Positive Advanced Hepatocellular Carcinoma (HCC) Subjects
An Open-label Phase 2 Trial of Dual TORC1/TORC2 Inhibitor ATG-008 in HBV+ Advanced Hepatocellular Carcinoma (HCC) Subjects Who Have Received at Least One Prior Line of Systemic Therapy (TORCH)
1 other identifier
interventional
73
3 countries
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hepatocellular-carcinoma
Started Aug 2018
Typical duration for phase_2 hepatocellular-carcinoma
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedStudy Start
First participant enrolled
August 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2022
CompletedJuly 10, 2023
January 1, 2023
4 years
June 20, 2018
July 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (7)
OS
365 DAYS
TTP
365 DAYS
PFS
365 DAYS
DCR
365 DAYS
DOR
365 DAYS
- +2 more secondary outcomes
Other Outcomes (2)
Potential biomarkers in plasma and tumor tissues
365 DAYS
Additional metabolites of ATG-008 in plasma and urine
Day 1 - Day 15
Study Arms (1)
ATG-008
EXPERIMENTALTo 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male or female aged from 18 to 70 years (inclusive) at the time when the ICF is signed.
- Confirmed diagnosis of HCC.
- Unresectable stage B or C HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging.
- HBV positive by serum test.
- Received at least one prior line of systemic therapy.
- ECOG performance status score of 0 or 1.
- Satisfactory serum chemistry results
- Adequate bone marrow function
- Child-Pugh A without encephalopathy.
- All subjects who participated in the study had to take reliable contraceptive measures within the trial and 3 months of after the trial.
You may not qualify if:
- Symptomatic central nervous system metastases.
- Locoregional HCC therapy, systemic chemotherapy, hormonal therapy or investigational therapy within 4 weeks prior to Screening.
- Life expectancy of less than 3 months.
- Prior therapy with mTOR inhibitors.
- Prior organ transplant.
- Persistent diarrhea or malabsorption.
- Clinically significant bleeding.
- Known history of human immunodeficiency virus (HIV) infection.
- Uncontrolled intercurrent illness.
- Any condition that confounds the ability to interpret data from the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Oncology Hospital of Haerbin Medical University
Harbin, Heilongjiang, 150000, China
China People PLA 81 Hospital
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 District, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stephen Xie, PhD
Medical Monitor
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2018
First Posted
July 19, 2018
Study Start
August 7, 2018
Primary Completion
August 3, 2022
Study Completion
August 3, 2022
Last Updated
July 10, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share