AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab 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
- 招募中
- 入组人数
- 87
- 试验地点
- 40
- 主要终点
- Stage 1: Percentage of Participants with Adverse Events (AE)s
研究概览
简要总结
Stage 1: To optimize telisotuzumab adizutecan monotherapy dose to determine the recommended dose in participants with unresectable refractory metastatic colorectal cancer (mCRC) selected for the defined level of c-Met protein expression; To evaluate the efficacy of telisotuzumab adizutecan monotherapy dose as measured by objective response (OR) in participants with unresectable refractory mCRC selected for the defined level of c-Met protein expression.; To evaluate the safety of telisotuzumab adizutecan monotherapy in participants with unresectable refractory mCRC selected for the defined level of c-Met protein expression; Stage 2: To demonstrate the superiority of telisotuzumab adizutecan over LONSURF (Trifluridine and Tipiracil) plus bevacizumab in terms of objective response (OR); To demonstrate the superiority of telisotuzumab adizutecan over LONSURF (Trifluridine and Tipiracil) plus bevacizumab in terms of overall survival (OS).
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
- •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
Stage 1: Percentage of Participants with Adverse Events (AE)s
Stage 1: Percentage of Participants with With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator
Stage 1: Percentage of Participants with With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator
Stage 1: Percentage of Participants with PCS Electrocardiograms (ECGs) Findings as Assessed by the Investigator
Stage 1: Percentage of Participants with PCS Electrocardiograms (ECGs) Findings as Assessed by the Investigator
Stage 1: Percentage of Participants with PCS Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator
Stage 1: Percentage of Participants with PCS Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator
Stage 1 and Stage 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
Stage 1 and Stage 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
Stage 2: Overall Survival (OS)
Stage 2: Overall Survival (OS)
次要结局
- Stage 1 and Stage 2: Progression Free Survival (PFS) as Assessed by BICR
- Stage 1: OS
- Stage 1 and Stage 2: Duration of Response (DOR) as Assessed by BICR
- Stage 1 and Stage 2: Disease Control (DC) as Assessed by BICR
- Stage 1 and Stage 2: OR as Assessed by Investigator
- Stage 1 and Stage 2: PFS as Assessed by Investigator
- Stage 1 and Stage 2: DOR as Assessed by Investigator
- Stage 1: Maximum Observed Serum (or Plasma, for Payload) Concentration (Cmax) for Telisotuzumab Adizutecan
- Stage 1: Time to Cmax (Tmax) for Telisotuzumab Adizutecan
- Stage 1: Terminal Elimination Half-Life (t1/2) for Telisotuzumab Adizutecan
- Stage 1: Area Under the Serum (or Plasma, for Payload) Concentration Versus Time Curve (AUC) for Telisotuzumab Adizutecan
- Stage 1: Antibody Drug Conjugate (ADC) for Telisotuzumab Adizutecan
- Stage 1: Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload for Telisotuzumab Adizutecan
- Stage 1: Incidence of Anti-Drug Antibodies (ADAs) for Telisotuzumab Adizutecan
- Stage 1: Neutralizing Anti-Drug Antibodies (nADAs) for Telisotuzumab Adizutecan
- 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 QLQC30)
- 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
- Stage 2: Change from Baseline at C5D1 in in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
- Stage 2: Change from Baseline at C7D1 (SOC Arm) in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
- 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
- Stage 2: Change from Baseline at C7D1 (SOC Arm) in GHS/QoL as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
- Stage 1 and Stage 2: DC as Assessed by Investigator
研究者
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