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A Clinical Study of SI-B001 in Combination With Paclitaxel/Docetaxel in the Treatment of Recurrent and Metastatic HNSCC

StatusActive, Not Recruiting
PhasePhase 2
Started2021-12-22
View on ClinicalTrials.gov ↗
This Phase IIa study is a clinical trial to evaluate the safety and efficacy of SI-B001 in combination with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) who have experienced disease progression or intolerance to prior anti-PD-1 monoclonal antibody therapy with or without platinum-based chemotherapy, and who have received no more than second-line treatment.

Amendment history 2 changes detected by DataLookout

2026-08-27
Primary completion pushed: 2025-12 → 2026-12
2026-08-27
Completion pushed: 2025-12 → 2026-12
Trial Details
NCT Number NCT05054439
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 45 participants
Start Date 2021-12-22
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-01