NCT04189614终止1 期
A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
AbbVie38 个研究点 分布在 6 个国家目标入组 65 人开始时间: 2020年2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
- 终止
- 发起方
- 入组人数
- 65
- 试验地点
- 38
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is being done to determine the efficacy and safety of cofetuzumab pelidotin in the PTK7-expressing, recurrent non-small cell lung cancer (NSCLC) population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-small cell lung cancer (NSCLC) with PTK7-expressing tumor using an immunohistochemistry (IHC) assay previously validated at a designated laboratory
- •Recurrent NSCLC that has progressed after treatment with at least the following approved therapies with demonstrated clinical benefit: a platinum-based chemotherapy doublet and an immune checkpoint inhibitor for tumors without targetable genetic alterations; a platinum-based chemotherapy doublet and targeted agent(s) for tumors with targeted genetic alterations
- •Received ≤ 2 prior lines of systemic therapy, including no more than 1 line of systemic cytotoxic chemotherapy (≤ 3 prior lines for tumors treated with targeted agent(s) for genetic alterations, including no more than 1 line of systemic chemotherapy)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •Adequate bone marrow, renal, and hepatic function per the protocol
排除标准
- •Known uncontrolled metastases to the central nervous system (CNS). Participants with CNS metastases may be eligible provided that definitive therapy has been given, and participants are asymptomatic and off systemic steroids and anticonvulsants used for management of brain metastases for at least 2 weeks prior to the first dose of study drug
- •Unresolved clinically significant adverse events Grade ≥ 2 from prior anticancer therapy (with the exception of alopecia or anemia)
- •Has clinically significant medical condition(s) as described in the protocol
- •Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days prior to the first dose of study drug (no washout period required for participants on EGFR tyrosine kinase inhibitors). Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is not subject to a washout period
- •Received anti-cancer herbal therapies within 7 days prior to the first dose of study drug
研究组 & 干预措施
Cofetuzumab Pelidotin
Experimental
Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks
干预措施: Cofetuzumab Pelidotin (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 3 years
ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR).
次要结局
- Duration of Response (DOR)(Up to approximately 3 years)
- Progression Free Survival (PFS)(Up to approximately 3 years)
- Overall Survival (OS)(Up to approximately 3 years)
研究者
研究点 (38)
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