drugset
drugset / Trial / NCT05054439

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

NCT05054439 ↗

Phase 2 Active not recruiting 45 enrolled Sichuan Baili Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-12-22
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 35 mg/m2 —
Subject IZALONTAMAB Monoclonal antibody — Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 —

Indications

head and neck squamous cell carcinoma