Clinical trial · Interventional
Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer
NCT06762327CI-TRIAL-00084390not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In lung cancer, ensartinib is effective in improving the prognosis of ALK positive /MET exon 14 skipping patients. However, patients with ALK positive /MET14 exon skipping non-lung cancer solid tumors have limited treatment options in the absence of standard treatment. We hope to bring a new effective and safe treatment option to these patients more efficiently.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ensartinib | Drug | Ensartinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ensartinib
- interventionNames
- Drug: Ensartinib
Primary outcomes (2)
- measure
- progression-free survival
- timeFrame
- 2 years
- description
- time to progression or Intolerable toxicity occurred
- measure
- Overall responce rate
- timeFrame
- 1year
- description
- Proportion of patients with CR/PR response in the total population
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced/metastatic solid tumors other than primary lung cancer * Alk-positive or MET14 exon skipping mutation by IHC\\FISH\\NGS\\RT-PCR * Have no standard treatment after MDT discussion, or could not tolerate the standard treatment, or the patient refused the standard treatment * Adequate liver and kidney function * Adequate bone marrow function * ECOG PS 0-3 * Female subjects should not be pregnant. All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications Written informed consent provided Exclusion Criteria: * Active viral, bacterial, or fungal infection detected 2 weeks before enrollment * Pregnancy or lactation * receiving medications or herbal supplements with potent inducers of CYP3A4 (at least 3 weeks prior) * Any severe or uncontrolled systemic illness, including uncontrolled Hypertension and active bleeding, any nonadherence that the investigator considered to be detrimental to study participation or adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) * Ineligible cardiac function * Interstitial lung disease, drug-induced interstitial lung disease, previous history of radiation pneumonitis requiring steroid therapy, or any evidence of active interstitial lung disease * Lack of adequate bone marrow reserve or organ function
References
Publications (0)
Data not yet available
No reference posted for this study.