A Phase IB/II Clinical Study of the Safety, Tolerability and Efficacy of SHR-7367 in Combination With Anti-tumor Agents in Subjects With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stage 1 (IB Period): Dose-limiting toxicity (DLT).
研究概览
简要总结
This study aims to evaluate the safety and preliminary efficacy of SHR-7367 in combination with antineoplastic agents in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
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
- •Be able and willing to provide a written informed consent.
- •Age 18-75 years old (inclusive) at the time of signing the informed consent form.
- •ECOG performance status 0-
- •Life expectancy is not less than 12 weeks.
- •At least one measurable lesion per RECIST v1.
- •Adequate organ and marrow function as defined by the protocol.
排除标准
- •Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures.
- •Known hypersensitivity to any component of SHR-7367; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination.
- •Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose).
- •Surgery or chemotherapy within 4 weeks of the first dose of study treatment.
- •Active HBV/HCV/HIV infection.
- •Untreated and/or uncontrolled brain metastases.
- •Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study.
研究组 & 干预措施
SHR-7367 + SHR-1316 Group
SHR-7367 combined with SHR-1316.
干预措施: SHR-7367 Injection (Drug)
SHR-7367 + SHR-1316 Group
SHR-7367 combined with SHR-1316.
干预措施: SHR-1316 Injection (Drug)
SHR-7367 + SHR-1316 + AG Group
SHR-7367 combined with SHR-1316 and AG.
干预措施: SHR-7367 Injection (Drug)
SHR-7367 + SHR-1316 + AG Group
SHR-7367 combined with SHR-1316 and AG.
干预措施: SHR-1316 Injection (Drug)
SHR-7367 + SHR-1316 + AG Group
SHR-7367 combined with SHR-1316 and AG.
干预措施: Paclitaxel for Injection (Drug)
SHR-7367 + SHR-1316 + AG Group
SHR-7367 combined with SHR-1316 and AG.
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
SHR-7367 + AG Group
SHR-7367 combined with AG.
干预措施: SHR-7367 Injection (Drug)
SHR-7367 + AG Group
SHR-7367 combined with AG.
干预措施: Paclitaxel for Injection (Drug)
SHR-7367 + AG Group
SHR-7367 combined with AG.
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
结局指标
主要结局
Stage 1 (IB Period): Dose-limiting toxicity (DLT).
时间窗: Up to 28 days.
Stage 1 (IB Period): Adverse events (AEs).
时间窗: About 1 year.
Stage 1 (IB Period): Serious adverse events (SAEs).
时间窗: About 1 year.
Phase II: Investigator-assessed objective response rate (ORR).
时间窗: Assessed every 6 weeks, about 1 year.
次要结局
- Investigator-assessed objective response rate (ORR).(Assessed every 6 weeks, about 1 year.)
- Disease control rate (DCR).(Assessed every 6 weeks, about 1 year.)
- Duration of response (DoR).(Assessed every 6 weeks, about 1 year.)
- Progression Free Survival (PFS).(Assessed every 6 weeks, about 1 year.)
- Incidence and severity of Adverse events (AEs).(Assessed approximately once every 1 month, about 1 year.)