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X-396 (ensartinib)
X-396 (ensartinib) is a potent and selective inhibitor of the anaplastic lymphoma kinase (ALK) and ROS1 kinases.
X-396 (ensartinib) is a potent and selective inhibitor of the anaplastic lymphoma kinase (ALK) and ROS1 kinases. Used for Non-small cell lung cancer with ALK or ROS1 rearrangements, Metastatic non-small cell lung cancer with ALK or ROS1 rearrangements.
At a glance
| Generic name | X-396 (ensartinib) |
|---|---|
| Sponsor | Xcovery Holdings, Inc. |
| Drug class | ALK and ROS1 kinase inhibitor |
| Target | ALK, ROS1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
ALK and ROS1 are kinases that play a role in the development and progression of certain types of cancer. Ensartinib works by blocking the activity of these kinases, which can help to slow or stop the growth of cancer cells.
Approved indications
- Non-small cell lung cancer with ALK or ROS1 rearrangements
- Metastatic non-small cell lung cancer with ALK or ROS1 rearrangements
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Vomiting
- Anemia
- Thrombocytopenia
- Neutropenia
- Leukopenia
Key clinical trials
- Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial) (PHASE2)
- Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (PHASE2)
- Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer (PHASE1)
- Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (PHASE2)
- eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients (PHASE3)
- X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases (PHASE2)
- Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. (PHASE2)
- Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |