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

NCT06762327 | Not Yet Recruiting Phase 2

• 1 other identifier: BD-EN-IV018
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• progression-free survival

  time to progression or Intolerable toxicity occurred

  2 years

• Overall responce rate

  Proportion of patients with CR/PR response in the total population

  1year

Secondary Outcomes (4)

• Disease control rate

  1year

• Overall survival

  3 years

• Duration of responce

  3 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  3 years

Study Arms (1)

Ensartinib

EXPERIMENTAL

Drug: Ensartinib

Interventions

Ensartinib DRUG

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

Ensartinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Interventions

ensartinib

Central Study Contacts

Xiaowei Wei

CONTACT

025-52271000; gswxw@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chiefphysician

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 7, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 7, 2025

Record last verified: 2024-11