Phase 3: testing SYS6010 combined with Enlonstobart for Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma
This is a randomly assigned, open-label, multicenter phase Ⅲ trial to measure the how well it works and safety of SYS6010 combined with Enlonstobart injection versus Tislelizumab combined with chemotherapy (gemcitabine plus cisplatin) in patients with previously systemic treatment-who have not tried this kind of treatment before recurrent or metastatic nasopharyngeal carcinoma
Official registry: https://clinicaltrials.gov/study/NCT07925021 · CSPC Megalith Biopharmaceutical Co.,Ltd. · enrollment listed as 424
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are SYS6010 combined with Enlonstobart, or Tislelizumab combined with chemotherapy. The registry lists allocation as na. This is a randomly assigned, open-label, multicenter phase Ⅲ trial to measure the how well it works and safety of SYS6010 combined with Enlonstobart injection versus Tislelizumab combined with chemotherapy (gemcitabine plus cisplatin) in patients with previously systemic treatment-who have not tried this kind of treatment before recurrent or metastatic nasopharyngeal carcinoma
They plan to enroll about 424 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Randomized, Open-label, Multicenter Phase Ⅲ Trial to Evaluate the Efficacy and Safety of SYS6010 Combined With Enlonstobart Injection Versus Tislelizumab Combined With Chemotherapy (Gemcitabine Plus Cisplatin) in Patients With Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma
Interventions: SYS6010 combined with Enlonstobart, Tislelizumab combined with chemotherapy
Primary outcome (registry wording): Progression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- Histologically confirmed recurrent or metastatic nasopharyngeal carcinoma, with no prior systemic therapy for recurrent or metastatic nasopharyngeal carcinoma
- Willing to provide tumor tissue samples for testing of EGFR protein and PD-L1 expression. If sample collection is not feasible for certain reasons, eligibility will be determined by joint assessment of the investigator and sponsor
- At least one measurable lesion confirmed by CT or MRI per RECIST v1.1. The lesion has not received prior radiotherapy, or has demonstrated clear progression after prior radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Expected survival of the participant is ≥ 3 months
- Major organ function must meet the following criteria within 7 days prior to enrollment:
- 3\) Coagulation function: i. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (for participants not receiving anticoagulation therapy)
Who the registry excludes
- Known hypersensitivity to study drugs, any components of PD-1 inhibitors/gemcitabine/cisplatin, or humanized monoclonal antibody products
- Prior treatment with antibody-drug conjugates (ADCs) carrying topoisomerase I inhibitor payloads
- Participants who fail to meet the required washout periods will be excluded
- History of severe cardiovascular and cerebrovascular diseases within 6 months prior to the first dose of study intervention, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as clinically significant ventricular arrhythmias requiring intervention, third-degree atrioventricular block, etc.; Fridericia-corrected QT interval \>470 ms (Fridericia formula: QTcF=QT/RR⁰·³³, RR=60/heart rate);
- History of myocardial infarction, unstable angina, aortic dissection, angioplasty, or coronary artery bypass graft surgery;
- New York Heart Association (NYHA) class Ⅱ or higher heart failure, or left ventricular ejection fraction \<50% on screening assessment;
Public study contact (from the registry)
Clinical Trials Information Group officer
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Sun Yat-sen University Cancer Center — Guangzhou, Guangzhou, China (recruiting)
FAQ about this NCT record
Is NCT07925021 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07925021?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07925021?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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