New ALK inhibitor ensartinib tested in first human trial for lung cancer

NCT ID NCT01625234

Completed Disease control Sponsor: Xcovery Holdings, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new oral drug called ensartinib (X-396) for the first time in humans. It involved 131 people with advanced solid tumors, including those with ALK-positive non-small cell lung cancer. The goal was to find the safest dose and see if the drug could shrink tumors. The trial had two parts: a dose-finding phase and an expansion phase focused on ALK-positive lung cancer patients.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Ensartinib (X-396), an oral ALK inhibitor drug
What this could lead to: If it works, this could provide a new treatment option for people with ALK-positive non-small cell lung cancer that has stopped responding to other therapies.
What could go wrong: This is an early first-in-human study, so the drug may not prove effective or may cause unexpected side effects. Results are preliminary and need confirmation in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED SOLID TUMORS NON-SMALL CELL LUNG CANCER

Contacts and locations

Locations

City of Hope National Med Ctr

Duarte, California, 91010, United States
Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
New York University Langone Medical Center

New York, New York, 10016, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Stanford University

Stanford, California, 94305, United States
Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States
UCSD Moores Cancer Center

La Jolla, California, 92093, United States
University of Southern California Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
University of Wisconsin Carbone Cancer Ctr

Madison, Wisconsin, 53792, United States
Vanderbilt University

Nashville, Tennessee, 37240, United States
Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States

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