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

December 30, 2024 updated by: Xiaowei Wei, Nanjing First Hospital, Nanjing Medical University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaowei Wei
  • Phone Number: 025-52271000
  • Email: gswxw@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ensartinib
Drug: Ensartinib
ensartinib 225mg ,PO,QD,until disease progression or intolerable toxicity

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD-EN-IV018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solid Tumors

Clinical Trials on Ensartinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe