Hepatocellular CarcinomaPhase 2NCT03591965
Dual TORC1/TORC2 Inhibitor ATG-008 (CC-223) in HBV Positive Advanced Hepatocellular Carcinoma (HCC) Subjects
A Phase 2 study testing ATG-008 in people with Hepatocellular Carcinoma, run by Antengene Therapeutics Limited at 30 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- ATG-008
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 7 Aug 2018to 3 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
China19 sites
The first Hospital of Jilin University
Changchun
Hunan Province Oncology Hospital
Changsha
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
Daping Hospital
Chongqing
The first hospital of Chongqing medical university
Chongqing
Xiehe Hospital of Fujian Medical University
Fuzhou
Nanfang Hospital of Nanfang Medical University
Guangzhou
The first affiliated Hospital of Zhejiang University
Hangzhou
Zhejiang Province Oncology Hospital
Hangzhou
Oncology Hospital of Haerbin Medical University
Harbin, Heilongjiang, 150000
The first affiliated hospital of Anhui medical university
Hefei
The second affiliated hospital of Anhui medical university
Hefei
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
China People PLA 81 Hospital
Nanjing, Jiangsu, 210000
The first affiliated hospital of Guangxi Medical University
Nanning
Oncology Hospital of Fudan University
Shanghai
Zhongshan Hospital of Fudan University
Shanghai
General Hospital of the Northern War Zone of the Chinese People's Liberation Army
Shenyang
Tangdu Hospital of China PLA fourth medical university
Xi'an
South Korea6 sites
Dong-A University Hospital
Busan
Pusan National Univ. Hospital
Busan
Kyungpook National Univ. Hospital
Daegu
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Taiwan5 sites
China Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Medical University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital-Linkuo
Taoyuan
About this study
Official title: 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)
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- ATG-008
- Keywords
- HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-008Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ATG-008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak Plasma Concentration (Cmax)
Measured: Day 1 - Day 15
AUC
Area under the plasma concentration versus time curve (AUC)
Measured: 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.
Measured: 365 DAYS
ORR
Percentage of subjects with PR, or CR
Measured: 365 DAYS
Secondary outcomes (7)
OS
Kaplan-Meier estimate of Overall Survival
Measured: 365 DAYS
TTP
The time from the first dose date until disease progression
Measured: 365 DAYS
PFS
The time from the first dose date until disease progression or death from any cause
Measured: 365 DAYS
DCR
The percentage of subjects with CR, or PR or stable disease (SD)
Measured: 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
Measured: 365 DAYS
TTR
The time from the first dose date to the first documentation of response of PR or better.
Measured: 365 DAYS
6, 9 and 12 month of survival rate
Percentage of patients alive
Measured: 365 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start7 Aug 2018
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Why it stopped: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antengene Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Xie, PhD, Study director, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591965
- Sponsor's protocol ID
- ATG-008-HCC-001
- Status last verified
- Jan 2023
- First submitted
- 20 Jun 2018
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03591965
- Acronym / sponsor ID
- ATG-008-HCC-001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Antengene Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATG-008 | Experimental | Drug: ATG-008To 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-008Approximately 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. | Drug | ATG-008 |
Primary outcome
Cmax
Time frame: Day 1 - Day 15
Peak Plasma Concentration (Cmax)
AUC
Time frame: Day 1 - Day 15
Area under the plasma concentration versus time curve (AUC)
The incidence of treatment emergent adverse events (TEAEs) & SAE assessed by CTCAE v4.03
Time frame: 365 DAYS
The treatment emergent adverse events (TEAEs) \& SAE case No. in total subject No.
ORR
Time frame: 365 DAYS
Percentage of subjects with PR, or CR
7 secondary outcomes
OS
Time frame: 365 DAYS
TTP
Time frame: 365 DAYS
PFS
Time frame: 365 DAYS
DCR
Time frame: 365 DAYS
DOR
Time frame: 365 DAYS
TTR
Time frame: 365 DAYS
6, 9 and 12 month of survival rate
Time frame: 365 DAYS
Results and safety
The study was stopped early (reason given: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Xie, PhD study director
Medical Monitor
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATG-008 in people with Hepatocellular Carcinoma, run by Antengene Therapeutics Limited at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day 1 - Day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.