NCT07239596招募中1 期
An Open, Multicenter Phase Ib/II Clinical Study of SHR-8068 in Combination Anti-tumor Drugs for the Treatment of Advanced Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This study evaluated the safety and efficacy of SHR-8068 in combination anti-tumor drugs in the treatment of advanced renal cell carcinoma
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
- •Age 18 to 75 years old (including boundary values)
- •Volunteer to participate in this clinical study and sign informed consent;
- •ECOG score 0-1;
- •Expected survival ≥3 months;
- •Patients with locally advanced unresectable or metastatic clear cell renal cell carcinoma confirmed by histology or cytology;
- •Tumor tissue samples must be provided for testing
- •There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
- •Adequate bone marrow and organ function.
排除标准
- •Have previously used or are currently using HIF inhibitors.
- •Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
- •Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
- •Undergoing major surgical treatment within a certain period of time after the first administration of medication (excluding diagnosis) or expecting major surgical treatment during the study period.
- •There are severe gastrointestinal function abnormalities in clinical practice, which may affect the intake, transportation or absorption of drugs.
- •Suffering from other active malignant tumors within 3 years or at the same time.
- •Patients who have received organ transplants in the past (excluding corneal transplants).
- •A clinically significant thrombotic or embolic event occurred within 6 months prior to the first administration of the drug.
- •There are clinical symptoms or diseases of the heart that are not well controlled.
- •Active tuberculosis.
- •Moderate and severe ascites with clinical symptoms; Uncontrolled or moderate to excessive pleural effusion and pericardial effusion.
- •The toxicity and/or complications of previous intervention measures have not been restored to the level of NCI-CTCAE≤1 or the inclusion and exclusion criteria.
- •Subjects with active hepatitis B or active hepatitis C.
- •As determined by the researcher, there are other factors that may affect the research results or lead to the forced termination of this study midway
研究组 & 干预措施
SHR-8068+ Adebrelimab + Bevacizumab
Experimental
干预措施: SHR-8068；Adebrelimab ；Bevacizumab (Drug)
SHR-8068+ SHR-4610
Experimental
干预措施: SHR-8068 ; SHR-4610 (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 21days after the first administration of each subject
DLT defined as the Incidence and severity of adverse events
Overall response rate(ORR)
时间窗: from first dose to disease progression or death, whichever comes first, up to 3 years
Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator
次要结局
- Progression-free survival (PFS) by investigator(Until progression or death, assessed up to approximately 3 year)
- Duration of response (DOR) by investigator assessment(Until progression or death, assessed up to approximately 3 year)
- Disease control rate (DCR) by investigator assessment(Until progression, assessed up to approximately 3 year)
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)(until to 90 days after the last dose，assessed up to approximately 3 years)
研究者
研究点 (1)
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