A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC
Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
Summary
The main purpose
- To evaluate the efficacy of SI-B001 monotherapy RP2D in phase I clinical treatment of
recurrent and metastatic head and neck squamous cell carcinoma (non-nasopharyngeal
carcinoma).
- To evaluate the safety and tolerability of SI-B001 monotherapy RP2D in phase I clinical
treatment of recurrent and metastatic head and neck squamous cell carcinoma
(non-nasopharyngeal carcinoma).
2) Secondary purpose
- Evaluate the PK characteristics of the SI-B001.
- Evaluate the immunogenicity of SI-B001. 3) Exploratory purpose
- Explore biomarkers that predict efficacy, such as protein expression and/or gene
amplification of EGFR and/or HER3 in tumor pathology, and peripheral blood NRG1 levels.