NCT05819684招募中1 期
A Phase I Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4602 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
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
- 133
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicities (DLT)
研究概览
简要总结
This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
- •At least one measurable lesion based on RECIST v1.1 criteria;
- •ECOG PS score: 0-1 points;
- •Expected survival period ≥ 3 months;
- •Adequate organ function;
- •Must take one medically approved contraceptive measure;
- •Patients voluntarily joined the study and signed informed consent.
排除标准
- •Patients with known CNS metastasis or hepatic encephalopathy;
- •Suffering from peripheral neuropathy;
- •History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period;
- •Patients with any active, known or suspected autoimmune disorder;
- •With known severe allergic reactions to any other monoclonal antibodies;
- •Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;
- •Patients with other malignancies currently or within the past 5 years;
- •Uncontrolled cardiac diseases or symptoms;
- •With known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs);
- •Patients with other potential factors that may affect the study results.
研究组 & 干预措施
Part 1: Dose escalation
Experimental
干预措施: SHR-4602 for injection (Drug)
Part 2: PK expansion
Experimental
干预措施: SHR-4602 for injection (Drug)
Part 3: efficacy expansion
Experimental
干预措施: SHR-4602 for injection (Drug)
结局指标
主要结局
Dose Limiting Toxicities (DLT)
时间窗: From Day 1 to 21 days after first dose
Maximum tolerated dose (MTD)
时间窗: From Day 1 to 21 days after first dose
Incidence and severity of adverse events (AEs)
时间窗: From Day 1 to 90 days after last dose
Recommended Phase 2 dose (RP2D)
时间窗: From Day 1 to 90 days after last dose
次要结局
- DCR(the date of first dose up to 90 days after last dose)
- PK parameters of SHR-4602 for Injection: Cmax(the date of first dose to 30 days after last dose)
- PK parameters of SHR-4602 for Injection: AUC0-t(the date of first dose to 30 days after last dose)
- PK parameters of SHR-4602 for Injection: T1/2(the date of first dose to 30 days after last dose)
- ADA(the date of first dose up to 90 days after last dose)
- PK parameters of SHR-4602 for Injection: Tmax(the date of first dose to 30 days after last dose)
- ORR(the date of first dose up to 90 days after last dose)
- DOR(the date of first dose up to 90 days after last dose)
- PFS(the date of first dose up to 90 days after last dose)
研究者
研究点 (1)
Loading locations...
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