Study on Entrectinib for Treating Solid Tumors with Specific Gene Changes

Inclusion Criteria

• Have a confirmed diagnosis of a locally advanced or metastatic solid tumor with NTRK1/2/3, ROS1, or ALK gene changes.
• Provide a tumor sample for testing, unless it's not medically possible.
• Have measurable or evaluable disease.
• If cancer has spread to the brain or spinal fluid, it must be symptom-free or previously treated and controlled.
• Previous cancer treatments are allowed, except for specific inhibitors targeting Trk, ROS1, or ALK, unless you have CNS-only progression with ALK- or ROS1-rearranged NSCLC and have used crizotinib.
• Must have waited at least 2 weeks or 5 half-lives after previous chemotherapy or targeted therapy, whichever is shorter.
• Must have waited at least 4 weeks after antibody therapy.
• Must have waited at least 14 days after radiotherapy.
• Have a performance status score of 2 or less and a life expectancy of at least 4 weeks.
• Have adequate organ function.
• Be able to swallow the entrectinib pill whole.

Exclusion Criteria

• Currently participating in another treatment trial.
• Have previously used Trk, ROS1, or ALK inhibitors, except for crizotinib in specific cases.
• Have another cancer that could affect the study results.
• Have a history of bone disorders or issues with bone metabolism.
• Have not fully recovered from recent surgery.
• Have had heart failure or low heart function recently.
• Have a history of prolonged QTc interval not caused by medication.
• Have risk factors for a specific heart rhythm problem called torsades de pointes.
• Have severe nerve damage.
• Have active infections.
• Have digestive issues that affect absorption.
• Have lung diseases like interstitial lung disease or pneumonitis caused by certain medications.