A Phase Ib/II Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Phase Ib: Dose Exploration Part-The incidence of dose limiting toxicity (DLT) events
研究概览
简要总结
Phase Ib: Dose exploration: To assess the safety, tolerability, and determine the recommended Phase 2 dose (RP2D) of BC3402 in combination with durvalumab in subjects with advanced hepatocellular carcinoma (HCC) Phase II: Dose Expansion: To assess the antitumor activity of BC3402 in combination with durvalumab in subjects with advanced HCC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the study and sign an informed consent form;
- •Male or female aged ≥ 18 years and ≤ 75 years;
- •Patients with advanced hepatocellular carcinoma confirmed by histology or cytology, or cirrhosis which meets the clinical diagnostic criteria of hepatocellular carcinoma by the by American Association for the Study of Liver Disease (AASLD) (2018 edition);
- •ECOG performance status of 0 or 1;
- •HBV Patients with HBV infection must be treated with antiviral therapy to ensure adequate viral suppression prior to enrollment;
- •Adequate organ and marrow function;
- •Male or female subjects with childbearing potential must agree to use reliable contraceptive methods.
排除标准
- •Received local hepatic therapy within 4 weeks prior to initiation of the study drug;
- •History of hepatic encephalopathy within the past 12 months or a requirement for medications to prevent or control encephalopathy;
- •The subject has clinically significant ascites requiring therapeuticc peritonrocentesis or peritoneal drainage.
- •The subject has main portal vein thrombosis on baseline imaging;
- •Documented history of GI bleeding within the past 6 months or at a high risk of GI bleeding per the investigator's clinical judgement;
- •Current or prior use of systemic corticosteroids or other immunosuppressive agents within 2 weeks before initiation of study drug;
- •Prior treatment with any anti-TIM3 antibody;
- •Prior treatment with an anti-PD-1 or anti PD-L1 immune checkpoint inhibitor antibody (only applicable for dose expansion part).
- •Other protocol-defined Inclusion/Exclusion may apply.
研究组 & 干预措施
BC3402+Durvalumab
Subjects will receive BC3402 and Durvalumab in a treatment cycle.
干预措施: BC3402 injection (Drug)
BC3402+Durvalumab
Subjects will receive BC3402 and Durvalumab in a treatment cycle.
干预措施: Durvalumab injection (Drug)
结局指标
主要结局
Phase Ib: Dose Exploration Part-The incidence of dose limiting toxicity (DLT) events
时间窗: 28 Days
To assess the incidence of dose limiting toxicity (DLT) events at different doses of BC3402 in combination with durvalumab in the treatment of advanced HCC
Phase II: Dose Expansion Part-objective response rate (ORR)
时间窗: 2 years
To assess the ORR of BC3402 in combination with durvalumab in advanced hepatocellular carcinoma (according to RECIST v1.1)
Phase Ib: Dose Exploration Part-Safety
时间窗: 2 years
To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC.
次要结局
未报告次要终点