RecruitingPhase 2NCT06668961

A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

A Phase II Clinical Study to Evaluate the Safety and Efficacy of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy (SI-B001+SI-B003+ Platinum-based Chemotherapy) as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

60 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a open, multi-center phase II clinical study to explore the efficacy, safety and pharmacokinetic/pharmacodynamic characteristics of SI-B001+SI-B003 combined with platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two new bispecific antibody drugs — SI-B001 and SI-B003 — along with platinum-based chemotherapy as a first-line treatment for people with recurrent or metastatic squamous cell carcinoma of the head and neck (mouth, throat, and nearby areas). **You may be eligible if...** - You are 18–75 years old with recurrent or metastatic head and neck squamous cell carcinoma - You have not received prior chemotherapy for metastatic or recurrent disease - You have at least one measurable tumor on scans - You are in good health (ECOG ≤ 1) with adequate organ function - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - Your cancer is from the nasopharynx, salivary gland, paranasal sinus, skin, or unknown primary site - You have active brain metastases - You received radiotherapy or another clinical trial treatment within 4 weeks before starting - You are pregnant or breastfeeding 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.

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Interventions

DRUGSI-B001

Administration by intravenous infusion

DRUGSI-B003

Administration by intravenous infusion


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06668961


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