OncoMatch/Clinical Trials/NCT05668858
A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma
Is NCT05668858 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including SI-B001 and SI-B003 for squamous cell carcinoma of head and neck.
Treatment: SI-B001 · SI-B003 — Phase Ib: To observe the safety and tolerability of SI-B001+SI-B003 in combination and to identify RP2D in locally advanced or metastatic head and neck squamous cell carcinoma indications. Initial efficacy, pharmacokinetic characteristics and immunogenicity were evaluated. Phase II: To evaluate the efficacy of SI-B001+SI-B003 two-drug combination chemotherapy. Safety and tolerance, PK/PD, immunogenicity were evaluated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: chemotherapy administered as part of multimodal treatment for locally advanced disease
those who have received systemic chemotherapy, excluding chemotherapy administered as part of multimodal treatment for locally advanced disease
Cannot have received: chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other antitumor treatments
Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other antitumor treatments within 4 weeks before the first dose of the study drug
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%
Organ function levels must meet the requirements; No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%; Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN; Urine protein ≤1+ or ≤1000 mg/24h
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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