骨髄悪性腫瘍患者におけるSEA-CD70の安全性試験
基本情報
- NCT ID
- NCT04227847
- ステータス
- 募集中
- 試験のフェーズ
- 第1相
- 試験タイプ
- 介入
- 目標被験者数
- 178
- 治験依頼者名
- Seagen Inc.
概要
This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer. This study will have seven groups or "parts." * Part A will find out how much SEA-CD70 should be given to participants * Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with MDS. * Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with AML. * Part D will find out how much SEA-CD70 with azacitidine should be given to participants * Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML that has not been treated. * Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML. * Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.
対象疾患
介入
依頼者(Sponsor)
実施施設 (3)
国立研究開発法人国立がん研究センター中央病院
Kashiwa, Chiba, Japan(RECRUITING)
日本医科大学付属病院
Bunkyo-ku, Tokyo, Japan(RECRUITING)
国立大学法人山形大学医学部附属病院
Yamagata, Japan(RECRUITING)