進行癌および特定の遺伝子変異（Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS]）を有する患者における、BI 1701963単独投与およびBI 3011441との併用投与における安全かつ有効な投与量を見つけるための研究

基本情報

NCT ID

NCT04835714

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

8

治験依頼者名

Boehringer Ingelheim

概要

This is a study in adults with advanced cancer (solid tumours including non-small cell lung cancer and colorectal cancer) in whom previous chemotherapy was not successful. People who have a tumour with a KRAS mutation can participate in the study. A KRAS mutation makes cancer grow faster. The study tests 2 medicines called BI 1701963 and BI 3011441. BI 1701963 and BI 3011441 prevent activation of KRAS. The purpose of this study is to find out the highest dose of BI 1701963 alone and in combination with BI 3011441 the participants can tolerate. Another purpose is to check whether BI 1701963 in combination with BI 3011441 is able to make tumours shrink. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they get tablets of BI 1701963 and capsules of BI 3011441 once daily. The doctors regularly monitor the size of the tumour. Doctors also regularly record any unwanted effects and check participants' health.

対象疾患

介入

依頼者（Sponsor）

実施施設 (3)