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

DAIICHI SANKYO Co.,Ltd.0 个研究点目标入组 180 人开始时间: 2022年6月13日最近更新: 2025年1月14日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: DAIICHI SANKYO Co.,Ltd.
入组人数: 180
主要终点: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Dose Expansion)

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, datopotamab deruxtecan, ifinatamab deruxtecan, DS-3939)
•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 cardiac arrhythmia requiring treatment
•Lung-specific intercurrent clinically significant illnesses
•Has an uncontrolled infection requiring systemic therapy

Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Dose Expansion)

ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR).

Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator and Blinded Independent Central Review (Dose Escalation)
Duration of Response (DoR) Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review
Disease Control Rate (DCR) Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review
Clinical Benefit Rate (CBR) Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review

发起方