An Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- HRS4508 DLT
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS-4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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; Both men and women are welcome;
- •The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .
- •ECOG ratings of 0 or
- •Expected survival period ≥ 12 weeks.
- •At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
- •Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.
排除标准
- •Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
- •There have been significant severe infections and major surgeries in the past 4 weeks
- •Existence of previous or concurrent malignant tumors
- •Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
- •Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration;
研究组 & 干预措施
HRS-4508+ Capecitabine
干预措施: HRS-4508+ Capecitabine (Drug)
HRS-4508+ Trastuzumab
干预措施: HRS-4508+ Trastuzumab (Drug)
HRS-4508+ Trastuzumab+ Pertuzumab
干预措施: HRS-4508+ Trastuzumab+ Pertuzumab (Drug)
HRS-4508+ Trastuzumab+ Capecitabine
干预措施: HRS-4508+ Trastuzumab+ Capecitabine (Drug)
Trastuzumab+ Capecitabine
干预措施: Trastuzumab+ Capecitabine (Drug)
HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel
干预措施: HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel (Drug)
HRS-4508+ Trastuzumab + Nab-paclitaxel
干预措施: HRS-4508+ Trastuzumab + Nab-paclitaxel (Drug)
Trastuzumab+ Pertuzumab
干预措施: Trastuzumab+ Pertuzumab (Drug)
HRS-4508+SHR-A1811
干预措施: HRS-4508+SHR-A1811 (Drug)
结局指标
主要结局
HRS4508 DLT
时间窗: 3 weeks
HRS4508 MTD
时间窗: 12 weeks
HRS4508 RP2D
时间窗: 12 weeks
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
时间窗: 2 years
Objective response rate (ORR)
时间窗: 1 year
次要结局
- Blood concentrations of Paclitaxel for Injection(6 weeks)
- Blood concentrations of HRS-4508(15 weeks)
- Blood concentrations of SHR-A1811(9 weeks)
- Blood concentrations of Capecitabine(2 weeks)
- Objective response rate (ORR)(1 year)
- Best overall efficacy (BOR)(1 year)
- Duration of response (DoR)(1 year)
- Progression free survival (PFS)(1 year)
- Disease control rate (DCR)(1 year)
- Overall survival (OS)(2 year)
- The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)(2 years)