Recurrent or Metastatic Nasopharyngeal CancerPhase 2NCT06892431

JMT101 Combined With Mitoxantrone Liposome for Nasopharyngeal Cancer

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome, JMT101 injection and Capecitabine in people with Recurrent or Metastatic Nasopharyngeal Cancer and Patients Who Have Experienced Treatment Failure at Least Second-line Chemotherapy, run by Shanghai JMT-Bio Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This study is a randomized, open-label, multicenter Phase II clinical study, with the objective to assess the efficacy and safety of JMT101 Injection combined with Mitoxantrone Hydrochloride Liposome Injection in patients with recurrent/metastatic nasopharyngeal cancer who have failed at least two prior lines of… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Recurrent or Metastatic Nasopharyngeal Cancer, Patients Who Have Experienced Treatment Failure at Least Second-line Chemotherapy
What is being tested?: Mitoxantrone Hydrochloride Liposome, JMT101 injection and Capecitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: No sites listed yet
Study dates: 1 Apr 2025to 30 Apr 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to understand and voluntarily sign the written ICF;
Aged 18-75 years old (inclusive), male or female;
Patients with nasopharyngeal cancer who have experienced treatment failure after prior PD-(L)-1 inhibitor therapy and at least second-line chemotherapy (including at least one line containing platinum);
According to RECIST v1.1, there is at least one measurable lesion, and the lesion has not previously undergone radiotherapy or has shown definite progression after radiotherapy;
ECOG PS score of 0-1;
Estimated lifespan of at least 3 months;
Have adequate organ function, laboratory test meets the following criteria (has not received transfusion or hematopoietic stimulating factor treatment within 14 days):(1)Hematology: a. Absolute neutrophil count ≥1.5×109/L; b. Platelet count ≥100×109/L; c. Hemoglobin ≥90 g/L.(2)Liver function: a. Total bilirubin ≤1.0×ULN; for participants with metastases to liver, total bilirubin ≤1.5×ULN; b. Alanine aminotransferase and aspartate aminotransferase ≤1.5×ULN, for participants with metastases to liver, alanine aminotransferase and aspartate aminotransferase ≤2.5×ULN. (3)Renal function: Creatinine ≤1.5×ULN; or creatinine clearance ≥50 mL/min (calculated according to the Cockcroft-Gault formula).(4)Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN; activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
Women of childbearing potential must use highly effective contraception.

Who cannot join

Previously received EGFR monoclonal antibody therapy for recurrent/metastatic nasopharyngeal cancer;
Have previously received treatment with doxorubicin or other anthracyclines, and the cumulative dose of doxorubicin exceeds 350 mg/m2 (Equivalent dose calculation for anthracyclines: 1 mg doxorubicin = 2 mg epirubicin = 2 mg daunorubicin = 0.5 mg idarubicin = 0.45 mg mitoxantrone);
History of drug allergy to the active or inactive excipients of any study drug, or to drugs with similar chemical structure or class as these two drugs;
Have received anti-tumor treatments within 2 weeks prior to the first dose of study drug, including hormone therapy, biological therapy, immunization therapy, local perfusion of anti-tumor drugs, or traditional Chinese medicines and/or Chinese patent drugs indicated for the treatment of nasopharyngeal cancer;
Have received local radiotherapy (including radionuclide therapy such as strontium-89) within 2 weeks prior to the first dose of study drug; have received irradiation of more than 30% of bone marrow or have received wide-field radiotherapy within 4 weeks prior to randomization;
Uncontrolled serous cavity effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose;

Show all 19Show fewer

Have undergone major surgery or had severe traumatic injury within 4 weeks prior to the first dose of study drug, or it is expected to undergo major surgery during the study period. Some clinical procedures such as vascular access placement and aspiration biopsy are allowed;
Currently receiving long-term immunosuppression therapy (e.g., cyclosporine) or have other diseases requiring treatment with systemic corticosteroids (i.e., prednisone over 10 mg/day or other corticosteroids at equivalent physiological doses), excluding those receiving local glucocorticoid therapy via nasal spray, inhalation, or other routes;
Participants with metastases to meninges or spinal cord compression; participants with symptomatic and/or unstable brain metastasis, unless the participant has completed definitive treatment and has been stable for at least 2 weeks prior to randomization without the need for steroid therapy. Participants with asymptomatic brain metastases may be enrolled if the investigator assesses that there is no indication for immediate curative treatment;
Subjects who have taken strong CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose of study drug, or who cannot suspend the use of strong CYP3A4 inducers and inhibitors during the study;
Participants with a history of autoimmune diseases, a history of immunodeficiency, including positive for HIV, or other acquired or immunodeficiency congenital diseases, or a history of organ transplant;
Presence of active infection (e.g., the subject is receiving anti-infection therapy), including uncontrolled active hepatitis b, active hepatitis c, active syphilis, active tuberculosis, etc.; Patients with a history of human hepatitis B virus (HBV) infection may be considered for enrollment if they meet all of the following criteria: a. Have no co-infection with hepatitis C virus (HCV) and no history of HCV infection; b. Participants with active HBV infection may also be enrolled if they can receive at least 2 weeks of antiviral therapy before starting study treatment, and after treatment their HBV DNA is less than 100 IU/mL and transaminases are less than 1×ULN.
Severe or uncontrolled cardiovascular disorder requiring treatment, including but not limited to
Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally, or previous subtotal small bowel resection, etc., and have conditions that seriously affect gastrointestinal absorption as judged by the investigator.
Prior to initiating treatment, have not yet adequately recovered (i.e., to ≤ Grade 1, excluding hypodynamia or alopecia) from toxicities and/or complications caused by any interventions;
Participants with other malignant tumors currently or with a history of other active malignant tumors within 5 years prior to the first study treatment (except for clinically cured localized tumors;
History of interstitial lung disease (ILD), history of drug-induced ILD, history of radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD;
Women who are pregnant or breastfeeding;
The researchers believe that the subjects are not suitable to participate in this clinical study due to other reasons.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

About this study

Official title: A Phase II Clinical Study of JMT101 Injection Combined With Mitoxantrone Liposome Injection in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Cancer Who Have Failed At Least Two Prior Lines of Treatment

Read the detailed description

Participants will be screened within 28 days prior to treatment, and those who meet the inclusion criteria and do not meet any of the exclusion criteria will be enrolled in this study. Enrolled participants will be randomly assigned in a 1:1:1 ratio to the following treatment groups, with each group planned to include 30-50 participants:

Mitoxantrone hydrochloride liposome will be administered for up to 6-8 cycles. After 6 cycles of administration, the investigator will decide whether to continue administration up to 8 cycles based on the patient's benefit-risk situation. JMT101 and the investigator-selected single-agent chemotherapy regimen will continue to be administered until progressive disease (PD) as assessed by the investigator according to RECIST v1.1 criteria, intolerable toxicity, withdrawal of informed consent by the subject, initiation of new anti-tumor treatment, loss to follow-up, death, or the end of the study, whichever occurs first.

Conditions: Recurrent or Metastatic Nasopharyngeal Cancer, Patients Who Have Experienced Treatment Failure at Least Second-line Chemotherapy
Being tested: Mitoxantrone Hydrochloride Liposome, JMT101 injection, Capecitabine, Docetaxel injection, Gemcitabine hydrochloride for injection
Medical subject headings: Recurrence, Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mitoxantrone Hydrochloride LiposomeDrug
Mitoxantrone Hydrochloride Liposome Injection 20mg/m2, or 16mg/m2, intravenous drip, Q4W.
JMT101 injectionDrug
Also called Recombinant Humanized Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Injection
JMT101 Injection 6 mg/kg, intravenous drip,
CapecitabineDrug
The dosage of capecitabine is 1000 mg/m2, taken orally twice daily, administered on D1-14 (Days 1-14) of each cycle, with every 3 weeks as one cycle (Q3W);
Docetaxel injectionDrug
The dosage of docetaxel is 75 mg/m2, administered via intravenous drip on D1 of each cycle, Q3W.
Gemcitabine hydrochloride for injectionDrug
The dosage of gemcitabine is 1000 mg/m2, administered via intravenous drip on D1 and D8 (Day 1 and Day 8) of each cycle, Q3W;

Study groups in NCT06892431
Study group	Role	What they receive
JMT101 injection + Mitoxantrone Hydrochloride Liposome Injection;	Experimental	Treatment Group A: JMT101 Injection 6 mg/kg, intravenous drip, Q2W. Mitoxantrone Hydrochloride Liposome Injection 16 mg/m2, intravenous drip, Q4W. Receives: Drug: Mitoxantrone Hydrochloride Liposome; Drug: JMT101 injection
JMT101 + Mitoxantrone Liposome;	Experimental	Treatment Group B: JMT101 Injection 6 mg/kg, intravenous drip, Q2W. Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2, intravenous drip, Q4W. Receives: Drug: Mitoxantrone Hydrochloride Liposome; Drug: JMT101 injection
Monotherapy chemotherapy regimens selected by the investigator.	Active comparator	the dosage of capecitabine is 1000 mg/m2, taken orally twice daily, administered on D1-14 (Days 1-14) of each cycle, with every 3 weeks as one cycle (Q3W); the dosage of gemcitabine is 1000 mg/m2, administered via intravenous drip on D1 and D8 (Day 1 and Day 8) of each cycle, Q3W; the dosage of docetaxel is 75 mg/m2, administered via intravenous drip on D1 of each cycle, Q3W. Receives: Drug: Capecitabine; Drug: Docetaxel injection; Drug: Gemcitabine hydrochloride for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective response rate (ORR) per RECIST v1.1
Measured: Up to approximately 30 months after the first participant is enrolled

Secondary outcomes (8)

Disease control rate (DCR) per RECIST 1.1
Measured: Up to approximately 30 months after the first participant is enrolled
Duration of response (DoR) per RECIST 1.1
Measured: Up to approximately 30 months after the first participant is enrolled
Progression free survival (PFS) per RECIST 1.1
Measured: Up to approximately 30 months after the first participant is enrolled
Overall survival(OS)
Measured: Up to approximately 30 months after the first participant is enrolled
Frequency and severity of AEs (NCI CTCAE 5.0)
Measured: Up to approximately 30 months after the first participant is enrolled
The plasma concentrations of JMT101, total mitoxantrone, and free mitoxantrone
Measured: Up to approximately 15 months after the first participant is enrolled
The incidence of JMT101 anti-drug antibodies (ADAs), titers, and neutralizing antibodies (NAbs, if applicable)
Measured: Up to approximately 15 months after the first participant is enrolled
The correlation between EGFR expression level and efficacy
Measured: Up to approximately 15 months after the first participant is enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202530 Apr 2027

First posted24 Mar 2025
Study start1 Apr 2025 (estimated)
Primary completion31 Dec 2025 (estimated)
Study completion30 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Recurrent or Metastatic Nasopharyngeal CancerStudies of the same condition, open and under way.
More trials run by Shanghai JMT-Bio Inc.The 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: Randomised
Intervention model: Parallel groups
Model description: Randomized, open-label, positive-controlled Phase II
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06892431
Sponsor's protocol ID: JMT101-019
Status last verified: Mar 2025
First submitted: 21 Mar 2025
Last updated: 25 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Clinical Trials Information Group officer

86-0311-69085587

ctr-contact@cspc.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 2
Becotatug Vedotin Plus Gemcitabine and a PD-1 Inhibitor in Recurrent or Metastatic Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma (NPC)
Active, not recruitingPhase 3
A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma (TAISHAN-301)
Nasopharyngeal Carcinoma
Not yet recruitingPhase 3
A Study of Anti-PD-1 Antibody With or Without BL-B01D1 as Maintenance Therapy Following Anti-PD-1 Antibody Plus Chemotherapy for the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (PANKU-NPC02)
Nasopharyngeal Carcinoma (NPC)

All Recurrent or Metastatic Nasopharyngeal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Study of JMT101 Injection Combined With Mitoxantrone Liposome Injection in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Cancer Who Have Failed At Least Two Prior Lines of Treatment
ClinicalTrials.gov ID: NCT06892431
Acronym / sponsor ID: JMT101-019
Conditions: Recurrent or Metastatic Nasopharyngeal Cancer, Patients Who Have Experienced Treatment Failure at Least Second-line Chemotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 150 participants (estimated)
Lead sponsor: Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
Study start: 1 Apr 2025 (estimated)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 30 Apr 2027 (estimated)
First posted: 24 Mar 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Randomized, open-label, positive-controlled Phase II

Arm	Type	Receives
JMT101 injection + Mitoxantrone Hydrochloride Liposome Injection;	Experimental	Drug: Mitoxantrone Hydrochloride Liposome, Drug: JMT101 injectionTreatment Group A: JMT101 Injection 6 mg/kg, intravenous drip, Q2W. Mitoxantrone Hydrochloride Liposome Injection 16 mg/m2, intravenous drip, Q4W.
JMT101 + Mitoxantrone Liposome;	Experimental	Drug: Mitoxantrone Hydrochloride Liposome, Drug: JMT101 injectionTreatment Group B: JMT101 Injection 6 mg/kg, intravenous drip, Q2W. Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2, intravenous drip, Q4W.
Monotherapy chemotherapy regimens selected by the investigator.	Active comparator	Drug: Capecitabine, Drug: Docetaxel injection, Drug: Gemcitabine hydrochloride for injectionthe dosage of capecitabine is 1000 mg/m2, taken orally twice daily, administered on D1-14 (Days 1-14) of each cycle, with every 3 weeks as one cycle (Q3W); the dosage of gemcitabine is 1000 mg/m2, administered via intravenous drip on D1 and D8 (Day 1 and Day 8) of each cycle, Q3W; the dosage of docetaxel is 75 mg/m2, administered via intravenous drip on D1 of each cycle, Q3W.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Able to understand and voluntarily sign the written ICF;
Aged 18-75 years old (inclusive), male or female;
Patients with nasopharyngeal cancer who have experienced treatment failure after prior PD-(L)-1 inhibitor therapy and at least second-line chemotherapy (including at least one line containing platinum);
According to RECIST v1.1, there is at least one measurable lesion, and the lesion has not previously undergone radiotherapy or has shown definite progression after radiotherapy;
ECOG PS score of 0-1;

Key exclusion criteria (19 listed)

Previously received EGFR monoclonal antibody therapy for recurrent/metastatic nasopharyngeal cancer;
Have previously received treatment with doxorubicin or other anthracyclines, and the cumulative dose of doxorubicin exceeds 350 mg/m2 (Equivalent dose calculation for anthracyclines: 1 mg doxorubicin = 2 mg epirubicin = 2 mg daunorubicin = 0.5 mg idarubicin = 0.45 mg mitoxantrone);
History of drug allergy to the active or inactive excipients of any study drug, or to drugs with similar chemical structure or class as these two drugs;
Have received anti-tumor treatments within 2 weeks prior to the first dose of study drug, including hormone therapy, biological therapy, immunization therapy, local perfusion of anti-tumor drugs, or traditional Chinese medicines and/or Chinese patent drugs indicated for the treatment of nasopharyngeal cancer;
Have received local radiotherapy (including radionuclide therapy such as strontium-89) within 2 weeks prior to the first dose of study drug; have received irradiation of more than 30% of bone marrow or have received wide-field radiotherapy within 4 weeks prior to randomization;

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
Mitoxantrone Hydrochloride LiposomeMitoxantrone Hydrochloride Liposome Injection 20mg/m2, or 16mg/m2, intravenous drip, Q4W.	Drug	JMT101 + Mitoxantrone Liposome;, JMT101 injection + Mitoxantrone Hydrochloride Liposome Injection;
JMT101 injectionAlso: Recombinant Humanized Anti-Epidermal Growth Factor Receptor Monoclonal Antibody InjectionJMT101 Injection 6 mg/kg, intravenous drip,	Drug	JMT101 + Mitoxantrone Liposome;, JMT101 injection + Mitoxantrone Hydrochloride Liposome Injection;
CapecitabineThe dosage of capecitabine is 1000 mg/m2, taken orally twice daily, administered on D1-14 (Days 1-14) of each cycle, with every 3 weeks as one cycle (Q3W);	Drug	Monotherapy chemotherapy regimens selected by the investigator.
Docetaxel injectionThe dosage of docetaxel is 75 mg/m2, administered via intravenous drip on D1 of each cycle, Q3W.	Drug	Monotherapy chemotherapy regimens selected by the investigator.
Gemcitabine hydrochloride for injectionThe dosage of gemcitabine is 1000 mg/m2, administered via intravenous drip on D1 and D8 (Day 1 and Day 8) of each cycle, Q3W;	Drug	Monotherapy chemotherapy regimens selected by the investigator.

Primary outcome

Objective response rate (ORR) per RECIST v1.1
Time frame: Up to approximately 30 months after the first participant is enrolled

8 secondary outcomes

Disease control rate (DCR) per RECIST 1.1
Time frame: Up to approximately 30 months after the first participant is enrolled
Duration of response (DoR) per RECIST 1.1
Time frame: Up to approximately 30 months after the first participant is enrolled
Progression free survival (PFS) per RECIST 1.1
Time frame: Up to approximately 30 months after the first participant is enrolled
Overall survival(OS)
Time frame: Up to approximately 30 months after the first participant is enrolled
Frequency and severity of AEs (NCI CTCAE 5.0)
Time frame: Up to approximately 30 months after the first participant is enrolled
The plasma concentrations of JMT101, total mitoxantrone, and free mitoxantrone
Time frame: Up to approximately 15 months after the first participant is enrolled
The incidence of JMT101 anti-drug antibodies (ADAs), titers, and neutralizing antibodies (NAbs, if applicable)
Time frame: Up to approximately 15 months after the first participant is enrolled
The correlation between EGFR expression level and efficacy
Time frame: Up to approximately 15 months after the first participant is enrolled

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 25 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Recurrent or Metastatic Nasopharyngeal Cancer

RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 2
Becotatug Vedotin Plus Gemcitabine and a PD-1 Inhibitor in Recurrent or Metastatic Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma (NPC)
Active, not recruitingPhase 3
A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma (TAISHAN-301)
Nasopharyngeal Carcinoma
Not yet recruitingPhase 3
A Study of Anti-PD-1 Antibody With or Without BL-B01D1 as Maintenance Therapy Following Anti-PD-1 Antibody Plus Chemotherapy for the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (PANKU-NPC02)
Nasopharyngeal Carcinoma (NPC)

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.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 19 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 25 Mar 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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) per RECIST v1.1 (time frame: Up to approximately 30 months after the first participant is enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06892431.

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 25 Mar 2025.