2024-517416-30-00招募中3 期
A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 10
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
- To evaluate the confirmed ORR per RECIST 1.1 as assessed by BICR
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
- •Has one of the following cancers: • Unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC); • Unresectable or metastatic adenocarcinoma of the biliary tract [intra- or extrahepatic cholangiocarcinoma (CCA) or gallbladder cancer (GBC)]; • Unresectable or metastatic colorectal adenocarcinoma; • unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma (GEJAC), or esophageal adenocarcinoma (EAC)
- •Has received prior therapy for the cancer
- •Has a life expectancy of at least 3 months
排除标准
- •Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis
- •Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- •Has uncontrolled or significant cardiovascular disease
- •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has not adequately recovered from major surgery or has ongoing surgical complications
结局指标
主要结局
Objective Response Rate (ORR)
Objective Response Rate (ORR)
次要结局
- Number of Participants who Experience One or More Adverse Events (AEs)
- Number of Participants who Discontinue Study Treatment due to an AE
- Duration of Response (DOR)
- Progression Free Survival (PFS)
- Overall Survival (OS)
研究者
Ken Hatogai
Scientific
Merck Sharp & Dohme LLC
研究点 (10)
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