A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 98
- 主要终点
- Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
研究概览
简要总结
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn:
- About the safety and how well people tolerate of patritumab deruxtecan
- How many people have the cancer respond (get smaller or go away) to treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The main inclusion criteria include but are not limited to the following:
- •Has one of the following cancers:
- •Unresectable or metastatic colorectal cancer.
- •Advanced and/or unresectable biliary tract cancer (BTC)
- •Hepatocellular carcinoma (HCC) not amenable to locoregional therapy
- •Locally advanced unresectable or metastatic gastroesophageal cancer
- •Has received prior therapy for the cancer.
- •Has recovered from any side effects due to previous cancer treatment
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
- •Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
- •Has evidence of any leptomeningeal disease
- •Has clinically significant corneal disease
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- •Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
研究组 & 干预措施
Patritumab deruxtecan
Participants receive patritumab deruxtecan intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.
干预措施: Patritumab deruxtecan (Biological)
结局指标
主要结局
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
时间窗: Up to 21 days
DLT will be defined as any drug-related adverse event observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next 21-day cycle. The number of participants in the dose-escalation phase who experience a DLT will be presented.
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
时间窗: Up to 21 days
DLT will be defined as any drug-related adverse event observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next 21-day cycle. The number of participants in the dose-escalation phase who experience a DLT will be presented.
Number of Participants with One or More Adverse Events (AEs)
时间窗: Up to approximately 44 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.
Number of Participants who Discontinue Study Intervention Due to an AE
时间窗: Up to approximately 44 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Objective Response Rate (ORR)
时间窗: Up to approximately 44 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
次要结局
- Duration of Response (DOR)(Up to approximately 44 months)
- Progression Free Survival (PFS)(Up to approximately 44 months)
- Overall Survival (OS)(Up to approximately 44 months)
- Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan(At designated time points (up to ~44 months))
- Trough Concentration (Ctrough) of Patritumab Deruxtecan(At designated time points (up to ~44 months))