Actively Recruiting
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
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-01-21
60
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sign informed consent and follow the study plan
- Any gender
- Age between 18 and 75 years
- Expected survival of at least 3 months
- Diagnosis of recurrent or metastatic head and neck squamous cell carcinoma
- Agree to provide tumor tissue samples from primary or metastatic lesions within 2 years
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Physical status score ECOG 0 or 1
- Previous cancer therapy side effects resolved to grade 1 or less (NCI-CTCAE v5.0)
- No severe heart dysfunction; left ventricular ejection fraction 50% or higher
- No blood transfusion or colony-stimulating factors within 14 days before study drug
- Coagulation function within specified limits (INR ≤1.5; APTT ≤1.5× upper limit)
- Urinary protein ≤1+ or ≤1000 mg/24h
- Fertile participants agree to use effective contraception from 7 days before first dose until 24 weeks after; females must have negative pregnancy test within 7 days before first dose
You will not qualify if you...
- Squamous cell carcinoma of nasopharynx, salivary gland, paranasal sinus, skin, or unknown primary site
- Patients suitable and willing for local treatments or who received systemic therapy except for locally advanced disease multimodal therapy
- Active central nervous system metastasis
- Participation in another clinical trial within 4 weeks before study drug
- Radiotherapy within 4 weeks before first study drug dose
- Use of traditional Chinese medicine with anti-tumor effects within 2 weeks
- Major surgery within 4 weeks before first study drug dose
- Use of systemic corticosteroids or immunosuppressants within 2 weeks before dosing
- Lung disease grade 3 or higher or history of interstitial lung disease
- Active infection requiring intravenous anti-infective treatment
- Previous immunotherapy with severe immune-related adverse events
- Live attenuated vaccine within 4 weeks before first study drug dose
- Immunomodulatory drugs within 14 days before first study drug dose
- Risk or history of active autoimmune disease
- Other cancers within 5 years before first dose
- Positive for HIV, active tuberculosis, active hepatitis B or C
- Poorly controlled high blood pressure or blood sugar
- History of severe heart or brain blood vessel disease
- Previous stem cell, bone marrow, or organ transplant
- Large or symptomatic fluid buildup not well controlled
- Allergy to recombinant humanized antibodies or components of SI-B001 or SI-B003
- Past severe infusion reactions to antibody therapy
- Pregnancy or breastfeeding
- Investigator judgment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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