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)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 30
- 主要终点
- Cmax
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
ATG-008
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.
干预措施: ATG-008 (Drug)
结局指标
主要结局
Cmax
时间窗: Day 1 - Day 15
Peak Plasma Concentration (Cmax)
AUC
时间窗: 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
时间窗: 365 DAYS
The treatment emergent adverse events (TEAEs) \& SAE case No. in total subject No.
ORR
时间窗: 365 DAYS
Percentage of subjects with PR, or CR
次要结局
- OS(365 DAYS)
- TTP(365 DAYS)
- 6, 9 and 12 month of survival rate(365 DAYS)
- PFS(365 DAYS)
- DCR(365 DAYS)
- DOR(365 DAYS)
- TTR(365 DAYS)