Safety, Tolerability, and Efficacy of SHR-A2102 in Combination With Adebrelimab, With SHR-8068, in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase IB/II Open-Label, Multicenter Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Determination of Recommended Phase II dose (RP2D)
研究概览
简要总结
This study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- •Age 18~70 years old.
- •Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer.
- •At least one measurable lesion per RECIST v1.1 criteria.
- •ECOG PS score: 0-1.
排除标准
- •Active or symptomatic brain metastases.
- •Previous diagnosis of any other malignancy.
- •Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.
- •Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
- •Uncontrolled tumor-related pain.
- •Subjects with severe cardiovascular and cerebrovascular diseases.
研究组 & 干预措施
SHR-A2102 in Combination with Adebrelimab and SHR-8068
干预措施: SHR-A2102 (Drug)
SHR-A2102 in Combination with Adebrelimab and SHR-8068
干预措施: Adebelimab (SHR-1316) (Drug)
SHR-A2102 in Combination with Adebrelimab and SHR-8068
干预措施: SHR-8068 (Drug)
结局指标
主要结局
Determination of Recommended Phase II dose (RP2D)
时间窗: From first dose of study treatment until the end of Cycle 1（up to 21 days）
Objective Response Rate (ORR)
时间窗: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)
The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.
Incidence and severity of AEs
时间窗: The observation period ended at the end of the 21-day period after the first dose of SHR-A2102 or Adebrelimab or SHR-8068 (up to 21 days)
次要结局
- Disease Control Rate (DCR)(From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months))
- Duration of Response (DoR)(From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)])
- Progression free Survival (PFS)(From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months))
- Overall Survival (OS)(From time of first dose of objective disease progression until the date of death (up to 24 months))