NCT07697586招募中2 期
A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 206
- 试验地点
- 4
- 主要终点
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
研究概览
简要总结
This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.
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
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- •Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.
- •Provide a tumor tissue sample.
- •At least one measurable lesion as assessed by the investigator according to RECIST v1.
- •ECOG performance status of 0 or
- •Life expectancy ≥ 12 weeks.
- •Adequate bone marrow, liver, kidney, and coagulation function.
- •Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.
排除标准
- •Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
- •Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS).
- •Uncontrolled systemic disease as judged by the investigator.
- •Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.
- •Presence of other moderate to severe lung disorders.
- •History of haemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks.
- •Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.
- •Active hepatitis b or hepatitis c or co-infection with HBV and HCV.
- •Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
- •Known hypersensitivity to the study drug or any of its components.
- •Pregnant or lactating women.
研究组 & 干预措施
SKB264 in combination with SKB118
Experimental
SKB264 at 4 mg/kg combined with SKB118 at 3 mg/kg, 10 mg/kg, 20 mg/kg, or other dose levels
干预措施: SKB264+SKB118 (Drug)
结局指标
主要结局
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
时间窗: From enrollment to the end of treatment at 24 months
adverse events (AEs) and serious adverse events (SAEs), dose-limiting toxicities (DLTs), clinically significant abnormal laboratory results, etc.
ORR(objective response rate)
时间窗: From enrollment to the end of treatment at 24 months
ORR as assessed by the investigator based on RECIST v1.1
次要结局
- DCR(Disease control rate )(From enrollment to the end of treatment at 24 months)
- DOR(duration of response )(From enrollment to the end of treatment at 24 months)
- PFS(progression-free survival)(From enrollment to the end of treatment at 24 months)
- OS (overall survival)(From enrollment to the end of treatment at 24 months)
研究者
研究点 (4)
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