A Study of SYS6010 Combined With Enlonstobart in Patients With Previously Systemic Treatment-Naive R/M Nasopharyngeal Carcinoma
NCT07925021, Phase 3, Recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of SYS6010 Combined With Enlonstobart in Patients With Previously Systemic Treatment-Naive R/M Nasopharyngeal Carcinoma | ClinicalTrials.gov |
| NCT number | NCT07925021 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 424 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | CSPC Megalith Biopharmaceutical Co.,Ltd. | ClinicalTrials.gov |
| Conditions | Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma | ClinicalTrials.gov |
| Interventions | SYS6010 combined with Enlonstobart, Tislelizumab combined with chemotherapy | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Progression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1. | From date of randomization to radiographic disease progression or death due to any cause, up to approximately 37 months. | ClinicalTrials.gov | |
| Secondary | Overall Survival | From date of randomization to death due to any cause, up to approximately 60 months. | ClinicalTrials.gov | |
| Secondary | ORR by Blinded Independent Central Review (BICR) based on RECIST v1.1. | Up to approximately 24 months | Objective Response Rate (ORR): Percentage of participants with confirmed complete response (CR) or partial response (PR) by Blinded Independent Central Review (BICR) based on RECIST v1.1. | ClinicalTrials.gov |
| Secondary | DoR by Blinded Independent Central Review (BICR) based on RECIST v1.1. | Up to approximately 37 months. | ClinicalTrials.gov | |
| Secondary | DCR by Blinded Independent Central Review (BICR) based on RECIST v1.1. | Up to approximately 24 months. | ClinicalTrials.gov | |
| Secondary | PFS by the investigator based on RECIST v1.1. | Up to approximately 37 months. | ClinicalTrials.gov | |
| Secondary | ORR by the investigator based on RECIST v1.1. | Up to approximately 24 months. | ClinicalTrials.gov | |
| Secondary | DoR by the investigator based on RECIST v1.1. | Up to approximately 37 months. | ClinicalTrials.gov | |
| Secondary | DCR by the investigator based on RECIST v1.1. | Up to approximately 24 months. | ClinicalTrials.gov | |
| Secondary | Quality of life: participant head and neck cancer-specific quality of life after treatment assessed using the European Organization for Research and Treatment of Cancer Quality of Life | Up to approximately 37 months. | Questionnaire Head and Neck Module (EORTC QLQ-H\&N35). Scores range from 0 to 100; higher scores mean worse quality of life / higher symptom burden. | ClinicalTrials.gov |
| Secondary | Incidence of Adverse Events (AE) assessed by CTCAE 6.0. | Up to approximately 37 months. | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment assessed by CTCAE 6.0. The investigator assesses the relationship of each event to the use of study drug. | ClinicalTrials.gov |
| Secondary | PK: Plasma concentration parameters (e.g., Cmax, AUC) for SYS6010 (toxin-conjugated antibody), total antibody, JS-1 and Enlonstobart. | Up to approximately 37 months. | Incidence, titer of anti-SYS6010 antibodies, and incidence of neutralizing antibodies (if applicable). PK assessments for SYS6010 (toxin-conjugated antibody, total antibody, JS-1) and Enlonstobart. | ClinicalTrials.gov |
| Secondary | Serum concentrations of toxin-bound antibody of SYS6010. | Up to approximately 37 months. | ClinicalTrials.gov | |
| Secondary | Anti-Drug Antibodies (ADA): Incidence of anti-SYS6010 antibodies. | Up to approximately 37 months. | ClinicalTrials.gov | |
| Secondary | Anti-Drug Antibodies (ADA): Titer of anti-SYS6010 antibodies. | Up to approximately 37 months. | ClinicalTrials.gov | |
| Secondary | Anti-Drug Antibodies (ADA): Incidence of neutralizing antibodies (if applicable). | Up to approximately 37 months. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)