An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 990
- 试验地点
- 72
- 主要终点
- Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR)
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 the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with refractory metastatic colorectal cancer (mCRC).
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 990 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally.
In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 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
- 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
- •Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.
- •Life expectancy >= 12 weeks per investigator assessment
排除标准
- •Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any Top-1 inhibitor ADC.
- •History of intolerance, allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil. This also includes patients with known rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
- •History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
- •History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
研究组 & 干预措施
Ph 3: Telisotuzumab Adizutecan + Bevacizumab
Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration.
干预措施: Telisotuzumab adizutecan (Drug)
Ph 3: Telisotuzumab Adizutecan + Bevacizumab
Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration.
干预措施: Bevacizumab (Drug)
Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab
Participants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration.
干预措施: Trifluridine/Tipiracil (Drug)
Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab
Participants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR)
时间窗: Up to Approximately 15 Months
Best overall response of confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Phase 3: Overall Survival (OS)
时间窗: Up to Approximately 36 Months
OS is defined as the time from date of randomization to the event of death from any cause.
次要结局
- Phase 3: Disease Control (DC) as assessed by BICR:(Up to Approximately 24 Months)
- Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domain at Week 13(Up to Approximately 13 Weeks)
- Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains(Up to Approximately 13 Weeks)
- Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR)(Up to Approximately 24 Months)
- Phase 3: Duration Of Response (DoR) as assessed by BICR(Up to Approximately 24 Months)
- Phase 3: Overall Survival (OS) in Participants With c-Met Subgroup >= 10%, 3+(Up to Approximately 36 Months)
- Phase 3: Overall Survival (OS) in Participants With c-Met Subgroup < 10%, 3+(Up to Approximately 36 Months)