EUCTR2019-004483-22-NL进行中（未招募）1 期
A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants with HER2-expressing Gastric Cancer (DESTINY-Gastric03) - Ph1b/2 Study of Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 357
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations
- •2. Disease Characteristics:
- •a/Locally advanced, unresectable, or metastatic disease based on most recent imaging
- •b/For Part 1, 2, 3a, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results
- •c/For Part 3b, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results
- •3. For Part 1, progression on or after at least one prior trastuzumab-containing regimen
- •For Part 2 and Part 3, previously untreated for unresectable or metastatic adenocarcinoma of the stomach/GEJ/ esophagus with with HER2-positive (Part 2 and Part 3, Arm 3A) or HER2-low (Part 3, Arm 3B) status
- •4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1
- •5. Has protocol-defined adequate bone marrow and organ function including cardiac, renal and hepatic function
- •6. If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for female and 6 months (all treatment arms except Arm 2B) or 4 months (Arm 2B) for male patients
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 214
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 143
排除标准
- •1.History of active primary immunodeficiency, known HIV, active HBV or HCV infection.
- •2.Uncontrolled intercurrent illness.
- •3.History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
- •4.Lung-specific intercurrent clinically significant severe illnesses.
- •5.Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- •6.Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
- •7. Has spinal cord compression or clinically active central nervous system metastases.
研究者
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