PHASE 1/2, OPEN-LABEL, MULTICENTER, FIRST-IN-HUMAN STUDY OF DS-3939a IN SUBJECTS WITH ADVANCED SOLID TUMORS

Inoguchi Akihiro0 个研究点目标入组 430 人开始时间: 2023年7月15日最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. Sign and date the main Informed Consent Form (ICF), prior to the start of any study-specific qualification procedures.
•2. Adults >= 18 years of age on the day of signing the main ICF.
•3. Has a left ventricular ejection fraction (LVEF) >= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) within 28 days of enrollment.
•4. Has adequate organ function
•5. Measurable disease based on RECIST V1.1.
•6. ECOG performance status score of 0 or 1.
•Additional inclusion criteria for Part 1
•- Has a histologically or cytologically documented locally advanced, metastatic, or unresectable urothelial, non-small cell lung, breast, ovarian, or biliary tract cancers, or pancreatic ductal adenocarcinoma, regardless of any molecular subtypes.
•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 core needle biopsy samples obtained during the Main Screening or Tissue Screening Period, or
•b.Alternative 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

•1. Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
•2. 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.
•3. Has multiple primary malignancies, except adequately resected nonmelanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for >= 3 years.
•4. 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.
•5. Has active human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid (RNA) viral load and cluster of differentiation 4 (CD4) count.
•6. Has evidence of active 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).
•7. Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
•8. Has an active, known, or suspected autoimmune disease.
•9. Current participation in other therapeutic investigational procedures, except for participation in LTFU without any investigational treatment.

发起方

Inoguchi Akihiro