進行固形悪性腫瘍患者を対象としたイフィナタマブ デルクステカン（DS-7300a、I-DXd）の試験
基本情報
- NCT ID
- NCT04145622
- ステータス
- 募集中
- 試験のフェーズ
- 第1/第2相
- 試験タイプ
- 介入
- 目標被験者数
- 250
- 治験依頼者名
- Daiichi Sankyo
概要
This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts. The primary purpose of the parts are: * Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd). * Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent. This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: * they withdraw * their disease gets worse * they experience unacceptable side effects.
対象疾患
介入
実施施設 (9)
公益財団法人がん研究会 有明病院
Tokyo, Japan(RECRUITING)
埼玉県立がんセンター
Saitama, Japan(RECRUITING)
愛知県がんセンター
Aichi, Japan(RECRUITING)
近畿大学東洋医学研究所附属診療所
Ōsaka-sayama, Japan(RECRUITING)
国立研究開発法人国立がん研究センター中央病院
Tokyo, Japan(RECRUITING)
地方独立行政法人 静岡市立静岡病院
Shizuoka, Japan(RECRUITING)
北海道大学病院
Hokkaido, Japan(RECRUITING)
大阪大学医学部附属病院
Osaka, Japan(RECRUITING)
昭和医科大学病院
Tokyo, Japan(RECRUITING)