Solid TumorsPhase 2NCT06762327
Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer
A Phase 2 study testing Ensartinib in people with Solid Tumors, run by Nanjing First Hospital, Nanjing Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Ensartinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2025to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Ensartinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsartinibDrug
ensartinib 225mg ,PO,QD,until disease progression or intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Ensartinib | Experimental | Not described Receives: Drug: Ensartinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
time to progression or Intolerable toxicity occurred
Measured: 2 years
Overall responce rate
Proportion of patients with CR/PR response in the total population
Measured: 1year
Secondary outcomes (4)
Disease control rate
Proportion of patients with CR/PR/SD response in the total population
Measured: 1year
Overall survival
time to death
Measured: 3 years
Duration of responce
time from first assessment of CR or PR to the first assessment of PD or death
Measured: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
The safety of Ensartinib treatment will be assessed according to CTCAE v5.0 criteria observed over the whole treatment period.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start28 Feb 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaowei Wei, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762327
- Sponsor's protocol ID
- BD-EN-IV018
- Status last verified
- Nov 2024
- First submitted
- 23 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer
- ClinicalTrials.gov ID
- NCT06762327
- Acronym / sponsor ID
- BD-EN-IV018
- Conditions
- Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ensartinib | Experimental | Drug: Ensartinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensartinibensartinib 225mg ,PO,QD,until disease progression or intolerable toxicity | Drug | Ensartinib |
Primary outcome
progression-free survival
Time frame: 2 years
time to progression or Intolerable toxicity occurred
Overall responce rate
Time frame: 1year
Proportion of patients with CR/PR response in the total population
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Related trials for Solid Tumors
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Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ensartinib in people with Solid Tumors, run by Nanjing First Hospital, Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaowei Wei (025-52271000, gswxw@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.