固形腫瘍を有する成人患者を対象としたKK2269の研究

基本情報

NCT ID

NCT06266299

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

101

治験依頼者名

Kyowa Kirin Co., Ltd.

概要

This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269. In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies. In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible.

対象疾患

介入

依頼者（Sponsor）

実施施設 (3)