NCT06083870招募中1 期
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
Lu Shun1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年12月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- maximal tolerance dose (MTD) of Oba01
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
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 agreement to provide written informed consent.
- •Man or woman ≥ 18 years and ≤75 years of age at the time of enrollment.
- •Histologically and/or cytologically-confirmed locally advanced or metastatic NSCLC.
- •Measurable lesion according to RECIST 1.
- •Progression after systemic treatment for advanced NSCLC.
- •Available archived paraffin-embedded or fresh tumor tissue from the primary tumor or metastasis for submission to the central laboratory.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Measurable and/or non-measurable disease as per RECIST 1.1 criteria.
- •Adequate organ function as assessed by laboratory tests.
- •Male or female subjects of child-producing potential must agree to use avoidance of pregnancy measures during the study and for 6 months after the last day of treatment.
排除标准
- •Patient has received previous treatment with DR5 targeted regimen or antibody-MMAE conjugate.
- •Brain metastases unless asymptomatic, stable and not requiring steroids for at least 7 days prior to start of study treatment.
- •Subject with positive HCV-Ab, Anti-HIV or positive HBS-Ag with copies of HBV DNA > ULN.
- •Pregnancy, lactation, or breastfeeding.
研究组 & 干预措施
Oba01
Experimental
干预措施: Oba01 (Drug)
结局指标
主要结局
maximal tolerance dose (MTD) of Oba01
时间窗: DLT will be evaluated on 21 days of observation period
Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
次要结局
- Overall response rate(ORR)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)
- Duration of response (DOR)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Progression-free survival (PFS)(Up to approximately 2 years)
研究者
Lu Shun
Prof.
Shanghai Chest Hospital
研究点 (1)
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