進行固形癌および大腸癌におけるトポイソメラーゼ1阻害剤をベースとしたレジメンと併用したM9466（DDRiver 511）

基本情報

NCT ID: NCT06509906
ステータス: 中止
試験のフェーズ: 第1相
試験タイプ: 介入
目標被験者数: 3
治験依頼者名: EMD Serono

概要

The purpose of this study is to evaluate the safety and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens. As such the combination with FOLFIRI (folinic acid, fluorouracil, irinotecan) and Bevacizumab will be evaluated in participants with colorectal cancer, to establish the M9466 maximum tolerated dose if observed and the recommended dose for expansion. Study Duration: After a Screening period of up to 28 days, enrolled participants will remain in the study until they have completed all the study visits or until they withdraw consent, are lost to follow-up, or die. Visit Frequency: The participants will come for a Screening Visit and 1 to 2 visits per treatment cycle. After end of study intervention period, the participants will come for an End of Treatment Visit and a Safety Follow-up Visit.

対象疾患

Advanced Solid Tumor

介入

M9466(DRUG)

Irinotecan(DRUG)

Folinic acid(DRUG)

Fluorouracil (5-FU)(DRUG)

Bevacizumab(DRUG)

Granulocyte colony stimulating factor (G-CSF)(DRUG)

依頼者（Sponsor）

Emd Serono Research & Development Institute(INDUSTRY)

Merck Kgaa, Darmstadt, Germany(INDUSTRY)

実施施設 (1)

国立研究開発法人国立がん研究センター中央病院

Chūōku, Japan