Hepatocellular Carcinoma
Conditions
Keywords
HCC
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.
Interventions
DRUGATG-008
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.
Sponsors
Antengene Therapeutics Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged from 18 to 70 years (inclusive) at the time when the ICF is signed. 2. Confirmed diagnosis of HCC. 3. Unresectable stage B or C HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. 4. HBV positive by serum test. 5. Received at least one prior line of systemic therapy. 6. ECOG performance status score of 0 or 1. 7. Satisfactory serum chemistry results 8. Adequate bone marrow function 9. Child-Pugh A without encephalopathy. 10. All subjects who participated in the study had to take reliable contraceptive measures within the trial and 3 months of after the trial.
Exclusion criteria
1. Symptomatic central nervous system metastases. 2. Locoregional HCC therapy, systemic chemotherapy, hormonal therapy or investigational therapy within 4 weeks prior to Screening. 3. Life expectancy of less than 3 months. 4. Prior therapy with mTOR inhibitors. 5. Prior organ transplant. 6. Persistent diarrhea or malabsorption. 7. Clinically significant bleeding. 8. Known history of human immunodeficiency virus (HIV) infection. 9. Uncontrolled intercurrent illness. 10. Any condition that confounds the ability to interpret data from the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 365 DAYS | Percentage of subjects with PR, or CR |
| The incidence of treatment emergent adverse events (TEAEs) & SAE assessed by CTCAE v4.03 | 365 DAYS | The treatment emergent adverse events (TEAEs) & SAE case No. in total subject No. |
| Cmax | Day 1 - Day 15 | Peak Plasma Concentration (Cmax) |
| AUC | Day 1 - Day 15 | Area under the plasma concentration versus time curve (AUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TTP | 365 DAYS | The time from the first dose date until disease progression |
| DCR | 365 DAYS | The percentage of subjects with CR, or PR or stable disease (SD) |
| 6, 9 and 12 month of survival rate | 365 DAYS | Percentage of patients alive |
| PFS | 365 DAYS | The time from the first dose date until disease progression or death from any cause |
| DOR | 365 DAYS | 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 |
| TTR | 365 DAYS | The time from the first dose date to the first documentation of response of PR or better. |
| OS | 365 DAYS | Kaplan-Meier estimate of Overall Survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Potential biomarkers in plasma and tumor tissues | 365 DAYS | 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 |
| Additional metabolites of ATG-008 in plasma and urine | Day 1 - Day 15 | Additional metabolites of ATG-008 in plasma and urine, and the extent of their urinary excretion/clearance |
Countries
China, South Korea, Taiwan
Outcome results
None listed