A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in Patients With Advanced Biliary Tract Tumors.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) by RECIST V1.1
研究概览
简要总结
The study was designed to evaluate the efficacy and safety of HRS-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old, male or female.
- •Histologically or cytologically confirmed diagnosis of advanced biliary tract cancer.
- •Unresectable or metastatic advanced patients with progression or intolerance for ≥ one line of systemic therapy, including patients who metastasize during or within 6 months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvant therapy must include gemcitabine-based chemotherapy).
- •Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •ECOG performance status of 0-
- •With a life expectancy of ≥3 months.
- •Have adequate laboratory parameters and organ functions during the screening period.
排除标准
- •Known history of hypersensitivity to any components of HRS-4642 or adebrelimab.
- •Prior anti-tumor chemotherapy within 4 weeks before the study drug administration. Small molecular targeted drugs (including oral targeted drugs for other clinical trials) with a half-life of less than 5 or 7 days from the first medication.
- •Patients with untreated or active central nervous system tumor metastasis.
- •Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
研究组 & 干预措施
HRS-4642 monotherapy arm
Patients will receive HRS-4642 monotherapy at a fixed dose.
干预措施: HRS-4642 monotherapy (Drug)
combination therapy arm
Patients will receive HRS-4642 and adebrelimab combination therapy.
干预措施: HRS-4642 and adebrelimab combination therapy (Drug)
结局指标
主要结局
Objective response rate (ORR) by RECIST V1.1
时间窗: up 2 years
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
Adverse events(AEs), serious adverse events（SAEs）
时间窗: up 2 years
AEs and SAEs occurred from the first dose of treatment to 30 days after the last dose of HRS-4642 or 90 days after the last dose of adebrelimab (whichever comes late).
次要结局
- Disease control rate (DCR)(up 2 years)
- Progression-free survival (PFS)(up 2 years)
- Overall survival (OS)(up 2 years)
研究者
Jia Fan
M.D
Shanghai Zhongshan Hospital