RecruitingPhase 1Phase 2NCT05668858

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

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

130 participants

Start Date

Feb 10, 2023

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma of Head and Neck

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — SI-B001 and SI-B003, possibly with chemotherapy — in patients with advanced or metastatic head and neck squamous cell carcinoma (cancer in the mouth, throat, voice box, or surrounding areas). The goal is to assess safety and effectiveness. **You may be eligible if...** - You are 18–75 years old - You have confirmed head and neck squamous cell carcinoma of the mouth, throat, voice box, or hypopharynx - Your cancer is locally advanced or has spread to other parts of the body - You have at least one measurable tumor and your expected survival is at least 3 months - You are in good physical condition (ECOG score 0–1) **You may NOT be eligible if...** - You have other types of head and neck cancer (e.g., nasopharyngeal) - You are unable to provide a tumor tissue sample - You have uncontrolled infections, severe organ disease, or another active cancer - Your expected survival is less than 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.