NCT07308106招募中2 期
A Phase II Clinical Study to Evaluate the Safety and Efficacy of SKB571 for Injection as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities
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
- 70
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The aim of the study to evaluate the safety and efficacy of SKB571 for injection as monotherapy in patients with locally advanced or metastatic Non-Small Cell Lung Cancer with MET abnormalities. 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
- •Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
- •Participants with histologically or cytologically confirmed NSCLC.
- •Locally advanced or metastatic NSCLC with MET Abnormalities that has progressed after standard therapy.
- •At least one measurable lesion as assessed by the investigator according to RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose.
- •Life expectancy ≥ 3 months as assessed by the investigator.
- •Adequate organ and bone marrow function.
- •Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
- •Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.
排除标准
- •Participants with known active central nervous system (CNS) metastasis, and/or carcinomatous meningitis, brainstem metastasis, metastases to spinal cord, or spinal cord compression.
- •Participants with other malignant tumors within 3 years prior to the first dose.
- •Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- •Presence of severe and/or uncontrolled concomitant diseases.
- •Participants with a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis.
- •Clinically severe lung damage due to complications of lung disorder.
- •Risk of esophagotracheal fistula or esophagopleural fistula, or tumor invasion or compression of surrounding vital organs and blood vessels.
- •Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade
- •Known active pulmonary tuberculosis.
- •Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
- •Active hepatitis B and hepatitis C.
- •Positive test for human immunodeficiency virus (HIV) or a medical history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- •Known allergy or hypersensitivity to SKB571 or its excipients; or a history of severe allergy to other monoclonal antibodies.
- •Participants who have undergone major surgery within 4 weeks before the first dose or are expected to require major surgery during the study.
- •Serious infection within 4 weeks before the first dose.
- •Participants who have received systemic corticosteroid therapy with > 10 mg/day of prednisone or other immunosuppressive drugs within 2 weeks before the first dose of study treatment.
- •Participants who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study.
- •Pregnant or breastfeeding women.
- •Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors.
- •Any condition that, in the investigator's opinion, interferes with the evaluation of study treatment, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.
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
ORR
时间窗: Up to 24 months
Objective response rate (ORR) assessed by the investigator as per RECIST v1.1.
AE
时间窗: Up to 24 months
Incidence and severity of adverse events (AEs)
次要结局
- DCR(Up to 24 months)
- DOR(Up to 24 months)
- OS(Up to 24 months)
- PFS(Up to 24 months)
研究者
研究点 (1)
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