Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Phase2:ObjectiveResponse Rate (ORR)
研究概览
简要总结
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation
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
- •Able and willing to provide a written informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •advanced non-small cell lung cancer with HER2 expression , amplification, or mutation
- •has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.
- •There is at least one measurable lesion according to RECIST V1.1 criteria
排除标准
- •Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤
- •Has received HER2 antibody drug conjugates,
- •Central nervous system metastasis or meningeal metastasis with clinical symptoms
- •Has active infection requiring systemic treatment.
研究组 & 干预措施
SHR-A1811
SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment
干预措施: SHR-A1811 (Drug)
结局指标
主要结局
Phase2:ObjectiveResponse Rate (ORR)
时间窗: Subjects were evaluated on tumor imaging every 6 weeks after treatment initiation and every 12 weeks after 54 weeks, until imaging progression, initiation of new antitumor therapy, loss of follow-up, and death，appropriately to 3 years
As assessed by RECIST v1.1 , as assessed by independent review committee (IRC)
Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811
时间窗: From Day 1 to90 days after last dose ，appropriately to 3 years
Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)
Phase 1: Recommended Phase 2 dose (RP2D)
时间窗: 12 months
RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained
Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811
时间窗: From Day 1 to90 days after last dose ，appropriately to 3 years
Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)
Phase1: Maximum tolerated dose (MTD)
时间窗: 12 months
Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A1811 treatment
次要结局
- Phase 1：PK parameter ：Tmax of SHRA1811(appropriately to 3 years)
- Phase2:Overall survival (OS)(Approximately 5 years after last subject enrolled)
- Phase1:Immunogenicity of SHR-A1811(Immunogenicity sample collection time points include: within 30 min before administration of C1D1, C2D1, C3D1, C4D1, C6D1 and C8D1 starting from cycle 11 only in every 3 cycles ,appropriately to 3 years)
- Phase1:PK parameter: Cmax of SHR-A1811(appropriately to 3 years)
- Phase2:ObjectiveResponse Rate (ORR)(appropriately to 3 years)
- Phase2:Duration of response (DOR)(appropriately to 3 years)
- Phase2:Progression Free Survival (PFS)(appropriately to 3 years)
- Phase1:PK parameter: AUC0-t of SHR-A1811(appropriately to 3 years)
- Phase2:Disease control rate (DCR)(appropriately to 3 years)