NCT05054439

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

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, open label phase II clinical study is performed in patients with relapsed metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) progressed on prior 1st or 2nd line with anti-PD-1 mab ± platinum-based chemotherapy. This study is investigating the safety and efficacy of SI-B001 at optimal combination dose with paclitaxel in patients.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	SI-B001	Si-b001 is administered by intravenous drip once a week (QW). The first intravenous infusion is 120 min±10min. If the infusion reaction can be tolerated during the first infusion, the subsequent infusion can be completed in 60-120 min.
DRUG	Paclitaxel	The dosage of paclitaxel was 80mg/m2 QW. SI-B001 and paclitaxel were used on the same day. After SI-B001 infusion, paclitaxel was pretreated and injected for no less than 3 hours.

Timeline

• Start date: 2021-12-22
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-09-23
• Last updated: 2025-09-26

Locations

7 sites across 1 country: China