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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 80
- 主要终点
- Percentage of Participants with disease free survival (DFS) Event
研究概览
简要总结
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45 sites worldwide.
In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- •Surgical tumor material should be available for Signatera ctDNA personalized panel design.
- •Must have received at least 3 months of platinum-based doublet adjuvant and/or neoadjuvant 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 within 1 year either after the end of adjuvant therapy or after tumor resection in subjects who are receiving neoadjuvant therapy and begin treatment within 6 weeks after ctDNA positivity is confirmed (reported).
- •For participants with rectal cancer a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet must have been administered. Please note that short course radiation or long-course chemoradiation does not count towards this 3-month minimum of platinum-doublet perioperative and/or adjuvant therapy.
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.
研究组 & 干预措施
Standard of Care (SOC)
Participants will receive SOC, during the approximately 51 month study duration.
干预措施: Standard of Care (Drug)
Telisotuzumab Adizutecan Monotherapy
Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration.
干预措施: Telisotuzumab Adizutecan (Drug)
结局指标
主要结局
Percentage of Participants with disease free survival (DFS) Event
时间窗: Up to Approximately 51 Months
DFS is defined as the time from randomization to the time of first occurrence of first radiographic recurrence of colorectal cancer (CRC), (either local recurrence or distant metastases) as determined by the investigator, or death from any cause.
次要结局
- Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months(6 Months)
- Overall Survival (OS)(Up to Approximately 51 Months)