jRCT2031240653招募中不适用
[M24-064] AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AbbVie GK
- 入组人数
- 40
- 主要终点
- Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
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.
- •Subject has received the following regimens for the treatment of advanced colorectal cancer and has demonstrated progressive disease or intolerance to their last regimen.
- •Prior treatment regimens must have included a fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), irinotecan, oxaliplatin, and an anti-VEGF monoclonal antibody (unless locally not approved) and an anti-EGFR antibody if indicated.
- •Patients who have received adjuvant/neoadjuvant chemotherapy and had recurrence during or within 12 months of completion of the adjuvant/neoadjuvant chemotherapy can count the adjuvant/neoadjuvant therapy as one regimen of therapy for advanced disease.
- •Prior treatment of Regorafenib and/or Fruquintinib is also allowed.
- •Must not have received prior LONSURF (Trifluridine/Tipiracil) treatment.
- •Patients who are BRAFV600E or HER2 amplified should have received approved target therapy (unless locally not approved or clinically contraindicated).
- •Patients who are MSI-high/dMMR should have received approved immunotherapy (unless locally not approved or clinically contraindicated).
- •Patients who have other targetable mutations should have been treated with the appropriate drug as it becomes approved, unless clinically contraindicated.
- •Must not have received anticancer therapy used with an antineoplastic intent, including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study drug.
- •Note:Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is not subject to a washout period.
排除标准
- •Prior systemic regimen containing c-MET targeting antibody or 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
Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
时间窗: Stage 1 and Stage 2
Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
Percentage of Participants with Adverse Events (AE)s
时间窗: Stage 1
Percentage of Participants with Adverse Events (AE)s
Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator
时间窗: Stage 1
Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator
时间窗: Stage 1
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator
时间窗: Stage 1
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator
Overall Survival (OS)
时间窗: Stage 2
Overall Survival (OS)
次要结局
- DOR as Assessed by Investigator(Stage 1 and Stage 2)
- Maximum Observed Serum (or Plasma, for Payload) Concentration (Cmax) for ABBV-400(Stage 1)
- Progression Free Survival (PFS) as Assessed by BICR(Stage 1 and Stage 2)
- Duration of Response (DOR) as Assessed by BICR(Stage 1 and Stage 2)
- OR as Assessed by Investigator(Stage 1 and Stage 2)
- Disease Control (DC) as Assessed by BICR(Stage 1 and Stage 2)
- PFS as Assessed by Investigator(Stage 1 and Stage 2)
- OS(Stage 1)
- Incidence of Anti-Drug Antibodies (ADAs) for ABBV-400(Stage 1)
- Neutralizing Anti-Drug Antibodies (nADAs) for ABBV-400(Stage 1)
- Time to Cmax (Tmax) for ABBV-400(Stage 1)
- Terminal Elimination Half-Life (t1/2) for ABBV-400(Stage 1)
- Area Under the Serum (or Plasma, for Payload) Concentration Versus Time Curve (AUC) for ABBV-400(Stage 1)
- Antibody Drug Conjugate (ADC) for ABBV-400(Stage 1)
- Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload for ABBV-400(Stage 1)
- Change from Baseline at C5D1 (ABBV-400 Arm) 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)(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 C7D1 (SOC Arm) in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30(Stage 2)
- Change from Baseline at C5D1 (ABBV-400 Arm) in in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30(Stage 2)
- Change from Baseline at C5D1 (ABBV-400 Arm) 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 2)
研究者
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