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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

Myelodysplastic SyndromeAcute Myeloid Leukemia

介入

SEA-CD70(DRUG)
azacitidine(DRUG)
Venetoclax(DRUG)

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)