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Not yet recruiting NCT06762327

Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer

Phase II Interventional Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ensartinib.
Who it may be relevant to
Registry conditions: Solid Tumors. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Ensartinib
    ensartinib 225mg ,PO,QD,until disease progression or intolerable toxicity

Primary outcome measures

  • progression-free survival [Time frame: 2 years]
  • Overall responce rate [Time frame: 1year]
Secondary outcome measures (4)
  • Disease control rate [Time frame: 1year]
  • Overall survival [Time frame: 3 years]
  • Duration of responce [Time frame: 3 years]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06762327 · BD-EN-IV018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗