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

Nanjing Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Solid Tumors

Treatments: Drug: Ensartinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06762327

BD-EN-IV018

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ensartinib

Experimental group

Treatment:

Drug: Ensartinib