2024-518015-19-00招募中2 期
A Phase 2, Randomized, Open-Label Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to the Current Standard of Care in Subjects with Post Adjuvant ctDNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NED)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 9
- 主要终点
- Percentage of Participants with disease free survival (DFS) Event
研究概览
简要总结
To evaluate the efficacy of telisotuzumab adizutecan monotherapy as measured by disease free survival (DFS) by investigator.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- •Surgical tumor material should be available and must be submitted for Signatera™ personalized panel and assessment of c-Met protein levels.
- •Must have received at least 3 months of platinum-based doublet adjuvant chemotherapy but may not have been treated with topoisomerase inhibitors as part of adjuvant therapy.
- •Has no radiographic evidence of disease (NED) confirmed by chest, abdominal, and pelvic computed tomography (CT) scans within 6 weeks prior to Cycle 1 Day 1 (C1D1) dosing.
- •Circulating tumor deoxyribonucleic acid (ctDNA) positive after the end of adjuvant therapy and begin the treatment within 6 weeks after ctDNA is confirmed (reported).
排除标准
- •No availability of surgical tissue sample.
- •History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.
- •Treated or untreated brain or meningeal metastases.
结局指标
主要结局
Percentage of Participants with disease free survival (DFS) Event
Percentage of Participants with disease free survival (DFS) Event
次要结局
- Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months
- Overall Survival (OS)
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (9)
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