NCT07230405招募中2 期
A Phase II Study to Evaluate the Safety and Efficacy of SKB571 in Patients With Advanced Non-small Cell Lung Cancer
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 295
- 试验地点
- 2
- 主要终点
- AE
研究概览
简要总结
This is a multicenter, phase II study. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of SKB571 in patients with advanced non-small cell lung cancer. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
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
- •Subjects aged 18-75 years at the time of signing the informed consent form
- •Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC .
- •Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.
- •Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or
- •Subjects who are assessed by the investigator to have an expected survival of ≥ 12 weeks.
- •Subjects who have adequate organ function.
- •Subjects who have recovered from all toxicities due to prior therapy .
- •Male and female subjects must agree to use highly effective contraception methods during the study treatment.
- •Subjects who voluntarily sign the informed consent form.
排除标准
- •Subjects with known active or untreated central nervous system (CNS) metastases.
- •Subjects with other malignant tumors within 3 years prior to the first dose.
- •Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
- •Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.
- •Subjects with known allergy or hypersensitivity to SKB571 or its excipients.
- •Subjects with clinically severe lung injuries due to pulmonary complications.
- •History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
- •Subjects with major surgery within 28 days prior to the first dose.
- •Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study.
- •Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer.
- •Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment.
- •Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment.
- •Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses > 10 mg/d or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment.
- •Any condition that, in the opinion of the investigator, will interfere with the assessment of study treatment or the safety of the subject or the interpretation of the study results.
研究组 & 干预措施
SKB571 monotherapy
Experimental
干预措施: SKB571 for injection (Drug)
结局指标
主要结局
AE
时间窗: Up to 24 months
Incidence and severity of adverse events (AEs)
ORR
时间窗: Up to 24 months
Objective response rate (ORR) (assessed by the investigators as per RECIST v1.1)
次要结局
- PFS(Up to 24 months)
- DOR(Up to 24 months)
- OS(Up to 24 months)
- DCR(Up to 24 months)
研究者
研究点 (2)
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