OncoMatch/Clinical Trials/NCT07254585
SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma
Official title: An Open-label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of SYS6010 Combined With Immunotherapy in the Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Is NCT07254585 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including SYS6010 and Enlonstobart for head and neck squamous cell carcinoma.
Treatment: SYS6010 · Enlonstobart · Pembrolizumab — This study is an open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with immunotherapy in the recurrent or metastatic head and neck squamous cell carcinoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (CPS ≥ 1)
baseline PD-L1 positivity (CPS≥1) must be confirmed by the 22C3 antibody test
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic anti-tumor therapy
Exception: neoadjuvant or adjuvant therapy allowed if disease progression occurs at least 6 months after the last administration
Participants who have not previously received systemic anti-tumor treatment. If participants have received neoadjuvant or adjuvant therapy (or combination targeted therapy), they are eligible if disease progression occurs at least 6 months after the last administration.
Cannot have received: immunotherapy
For Enlonstobart group: Participants who have not previously received immunotherapy are included.
Lab requirements
Blood counts
major organ function must meet the criteria within 7 days prior to the first dose of the study intervention
Kidney function
major organ function must meet the criteria within 7 days prior to the first dose of the study intervention
Liver function
major organ function must meet the criteria within 7 days prior to the first dose of the study intervention
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07254585 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-tumor therapy, immunotherapy disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify