Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2020-09-17
Target enrollment:
Participant gender:
Summary
This is the first human study to use X-396 (ensartinib), a drug being developed for treatment
of advanced cancers. The initial purpose of the study is to determine the largest amount of
X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended
Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor
activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide
early information on how the body handles the drug (pharmacokinetics) and on the efficacy of
X-396.