NCT06754930招募中1 期
A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer
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
- 400
- 试验地点
- 1
- 主要终点
- Recommended phase II dose (RP2D)
研究概览
简要总结
This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.
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
- •Voluntary participation and written informed consent.
- •18-75 years older, no gender limitation.
- •Eastern Cooperative Oncology Group (ECOG) score: 0-
- •With a life expectancy ≥ 3 months.
- •Pathologically diagnosed NSCLC.
- •Be able to provide fresh or archived tumour tissue.
- •At least one measurable lesion according to RECIST v1.
- •Adequate organ function.
- •Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
排除标准
- •Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
- •Previous or co-existing malignancies.
- •Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
- •Uncontrollable tumor-related pain.
- •Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
- •Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
- •Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy.
- •With poorly controlled or severe cardiovascular disease.
- •Active hepatitis B and hepatitis C.
- •Patients with a history of immunodeficiency.
- •Severe infection 30 days before the first dose.
研究组 & 干预措施
Experimental group
Experimental
干预措施: SHR-1826 (Drug)
Experimental group
Experimental
干预措施: SHR-1316 (Drug)
Experimental group
Experimental
干预措施: SHR-9839 (Drug)
Experimental group
Experimental
干预措施: SHR-8068 (Drug)
Experimental group
Experimental
干预措施: Ametinib mesylate (Drug)
Experimental group
Experimental
干预措施: BP-102 (Drug)
Experimental group
Experimental
干预措施: Carboplatin (Drug)
结局指标
主要结局
Recommended phase II dose (RP2D)
时间窗: Screening up to study completion, an average of 1 year.
Adverse events (AEs)
时间窗: Screening up to study completion, an average of 1 year.
Objective response rate (ORR)
时间窗: Screening up to study completion, an average of 1 year.
次要结局
- Disease control rate (DCR)(Screening up to study completion, an average of 1 year.)
- Duration of response (DoR)(Screening up to study completion, an average of 1 year.)
- Progression-free survival (PFS)(Screening up to study completion, an average of 1 year.)
- Overall survival (OS)(Screening up to study completion, an average of 1 year.)
- Drug resistant antibody (ADA) to SHR-1826(Screening up to study completion, an average of 1 year.)
- Blood concentration of SHR-1826(Screening up to study completion, an average of 1 year.)
- Blood concentration of free toxin(Screening up to study completion, an average of 1 year.)
研究者
研究点 (1)
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