An Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BRII-5395 in Combination With Sintilimab and Bevacizumab in Participants With Advanced Hepatitis B Virus Related Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Adverse events (AEs) and serious AEs (SAEs)
研究概览
简要总结
This early phase (Phase 1) study will evaluate BRII 5395, administered in combination with two approved anticancer agents, sintilimab and bevacizumab, in patients with advanced liver cancer caused by chronic hepatitis B virus (HBV) infection. The primary objective of the study is to assess the safety and tolerability of the combination therapy, as well as to explore preliminary evidence of clinical benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of locally advanced or metastatic HCC that is deemed unsuitable for surgical resection or transplant.
- •BCLC stages Intermediate (B) or Advanced (C).
- •Failed at least first-line systemic therapy, including ICIs; and disease is not amenable to curative surgical and/or locoregional therapies.
- •Adequate bone marrow and organ function status.
- •Life expectancy > 3 months.
- •HBsAg > 0.05 IU/mL at screening.
排除标准
- •Any systemic anticancer therapy within specified period prior to the first dose of study treatment.
- •Any localized anticancer therapy within specified period prior to the first dose of study treatment.
- •History of anaphylactic hypersensitivity prior to the first dose of study treatment.
- •Known hypersensitivity to polyethylene glycol or any component of sintilimab or bevacizumab formulation, or any contraindications to sintilimab or bevacizumab.
- •Presence of cancer or metastasis in the central nervous system with clinical symptoms.
- •Remaining ≥ NCI-CTCAE grade 2 toxicities from previous anticancer therapy, unless otherwise specified.
- •Current or past history of infection with HIV, HCV, or active tuberculosis.
研究组 & 干预措施
BRII-5395 dose escalation
Participants will receive BRII-5395 at protocol-specified dose and schedule, and in combination with sintilimab 200 mg and bevacizumab 15 mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.
干预措施: BRII-5395 (Drug)
BRII-5395 dose escalation
Participants will receive BRII-5395 at protocol-specified dose and schedule, and in combination with sintilimab 200 mg and bevacizumab 15 mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.
干预措施: Sintilimab (Drug)
BRII-5395 dose expansion
Participants will receive BRII-5395 at a dose level selected from Arm 1, and in combination with sintilimab 200 mg and bevacizumab 15mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.
干预措施: BRII-5395 (Drug)
BRII-5395 dose expansion
Participants will receive BRII-5395 at a dose level selected from Arm 1, and in combination with sintilimab 200 mg and bevacizumab 15mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.
干预措施: Bevacizumab (Drug)
BRII-5395 dose expansion
Participants will receive BRII-5395 at a dose level selected from Arm 1, and in combination with sintilimab 200 mg and bevacizumab 15mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.
干预措施: Sintilimab (Drug)
BRII-5395 dose escalation
Participants will receive BRII-5395 at protocol-specified dose and schedule, and in combination with sintilimab 200 mg and bevacizumab 15 mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Adverse events (AEs) and serious AEs (SAEs)
时间窗: Up to 30 days post last dose
Abnormalities in laboratory and other clinical assessments
时间窗: Up to 30 days post last dose
Incidence and type of dose-limiting toxicities (DLTs)
时间窗: Up to 30 days post last dose
次要结局
- Overall survival (OS)(Up to 2 years)
- Objective response rate (ORR)(Up to 2 years)
- Disease control rat (DCR)(Up to 2 years)
- Duration of response (DOR)(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)