2024-516158-22-00招募中2 期
A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Confirmed objective response rate by RECIST v1.1 based on independent central review (ICR).
研究概览
简要总结
To assess the efficacy of T-DXd in patients with metastatic or unresectable tumors harboring specific HER2 activating mutations across tumor types.
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
- 是
入选标准
- •Adults ≥18 years old. Other age restrictions may apply as per local regulations.
- •Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations locally determined by NGS on tumor tissue, who have progressed following prior treatment or who have no satisfactory alternative treatment options.
- •Prior HER2 targeted therapy is permitted.
- •All patients must provide an FFPE tumor sample for retrospective central HER2 testing.
排除标准
- •HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma.
- •HER2 mutant NSCLC.
- •History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening
- •Lung-specific intercurrent clinically significant severe illnesses.
- •History of active primary immunodeficiency, known HIV, active HBV or HCV infection
- •Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
- •Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
- •Has spinal cord compression or clinically active central nervous system metastases.
结局指标
主要结局
Confirmed objective response rate by RECIST v1.1 based on independent central review (ICR).
Confirmed objective response rate by RECIST v1.1 based on independent central review (ICR).
次要结局
- 3) Progression free survival (PFS) based on ICR assessment.
- 5) Overall survival (OS).
- 4) Confirmed Objective Response Rate (ORR) based on investigator assessment.
- 6) Occurrence of adverse events (AEs) and serious adverse events (SAEs).
- 8) The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd.
- 1) Duration of response (DoR) based on ICR assessment.
- 2) Disease control rate (DCR) based on ICR assessment.
- 7) Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181.
研究者
Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (2)
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