jRCT2031230233招募中不适用
PHASE 1/2, OPEN-LABEL, MULTICENTER, FIRST-IN-HUMAN STUDY OF DS-3939a IN SUBJECTS WITH ADVANCED SOLID TUMORS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 470
- 主要终点
- -
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
- Single 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（—）
- 性别
- All
入选标准
- •Sign and date the main Informed Consent Form (ICF), prior to the start of any study-specific qualification procedures.
- •Adults >= 18 years of age on the day of signing the main ICF.
- •Has a left ventricular ejection fraction (LVEF) >= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) within 28 days of enrollment.
- •Has adequate organ function
- •Measurable disease based on RECIST V1.
- •ECOG performance status score of 0 or
- •Additional inclusion criteria for Part 1
- •Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors.
- •Additional inclusion criteria for Part 2
- •Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy.
- •Is able to provide either of the following baseline tumor samples:
- •a.Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period
- •Fresh core needle biopsy sample
- •Biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy (if the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual)
- •b.FFPE tumor tissue samples obtained by biopsy or surgery performed after the completion date of the most recent anticancer therapy regimen and within 6 months before signing the main ICF
排除标准
- •Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC
- •Has spinal cord compression or history of/clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- •Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for >= 3 years.
- •Has a history of noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
- •Has active or uncontrolled human immunodeficiency virus (HIV) infection.
- •Has evidence of active or uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, as manifested by the detectable viral load (HBV-deoxyribonucleic acid [DNA] or HCV-RNA, respectively).
- •Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
- •Has an active, known, or suspected autoimmune disease.
- •Current participation in other therapeutic investigational procedures, except for participation in LTFU without any investigational treatment.
结局指标
主要结局
-
Dose-limiting toxicities (DLT) Adverse events (AEs) Objective Response Rate (Part 2)
次要结局
- ORR
- DoR
- DCR
- TTR
- PFS
- OS
研究者
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