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

Phase 2

Not yet recruiting

• Conditions: Solid Tumors
• Interventions: Drug: Ensartinib

• Registration Number: NCT06762327
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Study Start: 2025-02-28
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ensartinib	Ensartinib	-

Primary Outcome Measures

Name	Time	Method
progression-free survival	2 years	time to progression or Intolerable toxicity occurred
Overall responce rate	1year	Proportion of patients with CR/PR response in the total population

Secondary Outcome Measures

Name	Time	Method
Disease control rate	1year	Proportion of patients with CR/PR/SD response in the total population
Overall survival	3 years	time to death
Duration of responce	3 years	time from first assessment of CR or PR to the first assessment of PD or death
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	3 years	The safety of Ensartinib treatment will be assessed according to CTCAE v5.0 criteria observed over the whole treatment period.