この研究は、BI 754091の安全かつ効果的な投与量を見つけることを目的とします。また、BI 754091とBI 754111の併用における安全かつ効果的な投与量を見つけることも目的とします。この研究は、異なる種類の癌を有するアジア人患者を対象に実施されます。

基本情報

NCT ID

NCT03433898

ステータス

完了

試験のフェーズ

早期第1相

試験タイプ

介入

目標被験者数

146

治験依頼者名

Boehringer Ingelheim

概要

The main objectives of the BI 754091 monotherapy dose-finding part (Part I) of the trial are to investigate the following items in advanced solid tumours: * Safety, tolerability, and pharmacokinetics (PK) of BI 754091 as monotherapy. * Maximum tolerated dose (MTD) and/or recommended dose (RD) of BI 754091 monotherapy. The main objectives of the Combination dose-finding part (Part II) of the trial are to investigate the following items in advanced solid tumours: * Safety, tolerability, and PK of the combination treatment of BI 754091 and BI 754111. * MTD and/or RD of the combination treatment of BI 754091 and BI 754111. The main objectives of the expansion part (Part III) of the trial are: * To further investigate the safety, tolerability, and PK of the RD of BI 754091 and BI 754111 combination in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or non-small cell lung cancer (NSCLC) * To explore the efficacy of the RD of the combination of BI 754091 and BI 754111 in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or NSCLC

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)