NCT05208177终止2 期
A Phase Ⅰb/Ⅱ Dose-exploration and Efficacy-expansion Study of SHR-1802 Combined With Camrelizumab for Injection and Famitinib Malate Capsules for the Treatment of Advanced Solid Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
To assess the safety and tolerability of SHR-1802 combined with camrelizumab and famitinib in subjects with advanced solid tumor and to determine the dose-limiting toxicity (DLT)，recommended phase II dose (RP2D) and assess objective response rate (ORR) assessed by the investigator based on RECIST v1.1 criteria.
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
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Has a life expectancy≥ 3 months;
- •At least one measurable lesion according to RECIST v1.1;
- •Pathologically confirmed advanced solid tumor;
- •Adequate bone marrow reserve and organ function.
排除标准
- •Have received prior therapy with camrelizumab, and famitinib;
- •Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the treatment;
- •Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the treatment;
- •Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- •Have known history of arterial/venous thrombosis within 6 months prior to the first dose of the treatment, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism;
- •Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the treatment;
- •Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, substance abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of medication.
研究组 & 干预措施
SHR-1802 for injection combined with Camrelizumab for Injection and Famitinib Malate Capsules
Experimental
干预措施: SHR-1802＋camrelizumab + famitinib (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 4 weeks
ORR
时间窗: up to 2 years
Objective Response Rate, determined according to RECIST v1.1 criteria
Recommended phase II dose (RP2D)
时间窗: up to 1 years
次要结局
- PFS assessed by investigator(up to 2 years)
- TTR(up to 2 years)
- 12-month OS rate(from the date of the first dose up to 2 years)
- AEs+SAEs(from the first drug administration to within 90 days for the last drug dose)
- Nab(up to 30 days after last dose)
- Concentration of drug in plasma(n the second cycle，predose 1 hour and 6 hours post-dose；In cycle 3, cycle 4, cycle 6, cycle 8, and cycle 10，predose 1 hour（each cycle is 21 days）)
- Count of T lymphocyte subsets(30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection)
- Percentage of T lymphocyte subsets(30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection)
- DOR(up to 2 years)
- ADA(up to 30 days after last dose)
- Concentration of drug in serum(0.5 hour before the first dose up to 30 days after last dose)
- DCR(up to 2 years)
- OS (overall survival)(up to 2 years)
研究者
研究点 (1)
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