NCT05668858

A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

A Phase Ib/II Clinical Study of SI-B001+SI-B003 Dual-drug No-combination or Combined Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Phase Ib: To observe the safety and tolerability of SI-B001+SI-B003 combination and to determine the recommended dose (RP2D) for Phase II clinical studies in locally advanced or metastatic head and neck squamous cell carcinoma indications. To evaluate the initial efficacy, pharmacokinetic characteristics and immunogenicity of SI-B001+SI-B003 in patients with locally advanced or metastatic head and neck squamous cell carcinoma. Phase II: To evaluate the efficacy of SI-B001+SI-B003 dual-agent chemotherapy in patients with locally advanced or metastatic head and neck squamous cell carcinoma. The safety, tolerability, PK/PD and immunogenicity of SI-B001+SI-B003 combined chemotherapy in patients with locally advanced or metastatic head and neck squamous cell carcinoma were evaluated.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	SI-B001	Administration by intravenous infusion
DRUG	SI-B003	Administration by intravenous infusion

Timeline

• Start date: 2023-02-10
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2022-12-30
• Last updated: 2025-09-26

Locations

1 site across 1 country: China