AndroMETa-CRC-064: An Open-Label, Randomized Global Dose Optimization Study Comparing Two Doses of Telisotuzumab Adizutecan (ABBV-400) Monotherapy in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
- 试验地点
- 102
- 主要终点
- Stage 1: Percentage of Participants with Adverse Events (AE)s
研究概览
简要总结
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and change in disease activity of intravenously (IV) infused telisotuzumab adizutecan in adult participants with c-Met protein above cutoff level refractory metastatic colorectal cancer (mCRC).
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms and each treatment arm receives a different dose of telisotuzumab adizutecan. Up to approximately 60 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study at approximately 80 sites in 7 countries.
Participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. The total study duration will be approximately 4 years.
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
- •Life expectancy >= 12 weeks per investigator assessment.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period prior to the first dose of the study drug.
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
排除标准
- •Prior systemic regimen containing c-MET targeting antibody/bispecific or Antibody Drug Conjugate (c-Met targeting Antibody Drug Conjugate [ADC]).
- •History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
- •Active infection as noted in the protocol.
结局指标
主要结局
Stage 1: Percentage of Participants with Adverse Events (AE)s
时间窗: Up to a Maximum of 4 Years
An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational drug.
Stage 1: Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator
时间窗: Up to a Maximum of 4 Years
Vital signs are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation (SpO2), and body temperature will be obtained at visits.
Stage 1: Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator
时间窗: Up to a Maximum of 4 Years
Percentage of participants with clinically significant ECGs findings as assessed by the investigator.
Stage 1: Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator
时间窗: Up to a Maximum of 4 Years
Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.
Stage 1 and Stage 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
时间窗: Up to a Maximum of 4 Years
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Stage 2: Overall Survival (OS)
时间窗: Up to a Maximum of 4 Years
OS is defined as the time from randomization to the event of death from any cause.
次要结局
- Stage 1 and Stage 2: Progression Free Survival (PFS) as Assessed by BICR(Up to a Maximum of 4 Years)
- Stage 1: OS(Up to a Maximum of 4 Years)
- Stage 1 and Stage 2: Duration of Response (DOR) as Assessed by BICR(Up to a Maximum of 4 Years)
- Stage 1 and Stage 2: Disease Control (DC) as Assessed by BICR(Up to a Maximum of 4 Years)
- Stage 1 and Stage 2: OR as Assessed by Investigator(Up to a Maximum of 4 Years)
- Stage 1 and Stage 2: PFS as Assessed by Investigator(Up to a Maximum of 4 Years)
- Stage 1 and Stage 2: DOR as Assessed by Investigator(Up to a Maximum of 4 Years)
- Stage 1: Maximum Observed Serum (or Plasma, for Payload) Concentration (Cmax) for Telisotuzumab Adizutecan(Up to a Maximum of 4 Years)
- Stage 1: Time to Cmax (Tmax) for Telisotuzumab Adizutecan(Up to a Maximum of 4 Years)
- Stage 1: Terminal Elimination Half-Life (t1/2) for Telisotuzumab Adizutecan(Up to a Maximum of 4 Years)
- Stage 1: Area Under the Serum (or Plasma, for Payload) Concentration Versus Time Curve (AUC) for Telisotuzumab Adizutecan(Up to a Maximum of 4 Years)
- Stage 1: Antibody Drug Conjugate (ADC) for Telisotuzumab Adizutecan(Up to a Maximum of 4 Years)
- Stage 1: Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload for Telisotuzumab Adizutecan(Up to a Maximum of 4 Years)
- Stage 1: Incidence of Anti-Drug Antibodies (ADAs) for Telisotuzumab Adizutecan(Up to a Maximum of 4 Years)
- Stage 1: Neutralizing Anti-Drug Antibodies (nADAs) for Telisotuzumab Adizutecan(Up to a Maximum of 4 Years)
- Stage 2: Change from Baseline at C5D1 in Physical Functioning as Measured by the Physical Functioning Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Up to a Maximum of 4 Years)
- Stage 2: Change from Baseline at C7D1 (Standard of Care [SOC] Arm) in Physical Functioning as Measured by the Physical Functioning Domain of the EORTC QLQ-C30(Up to a Maximum of 4 Years)
- Stage 2: Change from Baseline at C5D1 in in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30(Up to a Maximum of 4 Years)
- Stage 2: Change from Baseline at C7D1 (SOC Arm) in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30(Up to a Maximum of 4 Years)
- Stage 2: Change from Baseline at C5D1 in in Global Health Status (GHS)/QoL as Measured by the Physical Functioning Domain of the EORTC QLQ-C30(Up to a Maximum of 4 Years)
- Stage 2: Change from Baseline at C7D1 (SOC Arm) in GHS/QoL as Measured by the Physical Functioning Domain of the EORTC QLQ-C30(Up to a Maximum of 4 Years)