術後循環腫瘍DNA陽性大腸癌で、画像診断上疾患の所見がない成人患者を対象に、テリソツズマブ・アディズテカン単独または標準治療との併用による静脈内投与による有害事象および疾患活動性の変化を評価する研究

基本情報

NCT ID

NCT07023289

ステータス

募集中

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

140

治験依頼者名

AbbVie

概要

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45 sites worldwide. In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

対象疾患

介入

依頼者（Sponsor）

実施施設 (11)