Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects with Advanced Renal Cell Carcinoma and Ovarian Tumors

Inoguchi Akihiro0 个研究点目标入组 140 人开始时间: 2022年5月19日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Written informed consent
•- At least 18 years of age
•- Eastern Cooperative Oncology Group Performance Status score of 0 or 1
•- Availability of archived tumor tissue samples
•- Has a left ventricular ejection fraction (LVEF) >=50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before start of study treatment
•- Has adequate organ function within 7 days before the start of study treatment
•- Has an adequate treatment washout period prior to start of study treatment
•- Male participants with female partners of childbearing potential and female participants of child-bearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4 months (for males) and for at least 7 months (for females) after the last dose of study drug

•- Has had prior treatment with other CDH6-targeted agents
•- Has had prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan, DS-1062a, DS-7300a)
•- Has history or current presence of CNS metastases except for participants who have completed radiotherapy or surgery >=2 weeks before the start of study treatment and have no evidence of disease progression in the CNS and no requirement for chronic corticosteroid therapy within 2 weeks before the start of study treatment
•- 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 myocardial infarction or unstable angina within 6 months before start of study treatment
•- Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment
•- Lung-specific intercurrent clinically significant illnesses
•- Has an uncontrolled infection requiring systemic therapy

发起方

Inoguchi Akihiro