2024-518871-74-00招募中2 期
A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects with Locally Advanced or Metastatic Solid Tumors that Harbor MET Amplification
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
- 29
- 试验地点
- 10
- 主要终点
- Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR)
研究概览
简要总结
- To evaluate the efficacy of telisotuzumab adizutecan monotherapy as measured by OR (objective response) in subjects with locally advanced or metastatic solid tumors that harbor MET amplification
- To evaluate the safety and tolerability of telisotuzumab adizutecan monotherapy in subjects with locally advanced or metastatic solid tumors that harbor MET amplification
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Locally advanced/metastatic solid tumors with documented MET amplification via Local next generation sequencing (NGS) or Central NGS via FoundationOne Companion Diagnostic (F1CDx).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-Oncology (RANO) criteria as appropriate to tumor type.
- •Received prior systemic therapy appropriate for their tumor type and stage of disease and who have no satisfactory alternative therapy for advanced solid tumors that would be expected to provide a substantial survival benefit for their tumor type.
- •If participant has central nervous system (CNS) metastasis, these should be clinically asymptomatic or radiologically stable (i.e., without evidence of progression after definitive treatment
排除标准
- •Current, historical, or suspected (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids.
- •Any major, life-threatening conditions and life expectancy should be at least 12 weeks.
研究组 & 干预措施
Telisotuzumab adizutecan
Test
干预措施: Telisotuzumab adizutecan (Drug)
结局指标
主要结局
Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR)
Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR)
次要结局
- Duration of Response (DoR) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing
- Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing
- Disease Control (DC) as Assessed by ICR based on RECIST v1.1 or RANO criteria as appropriate to tumor type in subjects with MET amplified positivity determined by F1CDx testing
- OS in Participants with MET Amplified Positivity Determined by F1CDx Testing
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (10)
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