Actively Recruiting
A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
130
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow the study procedures
- Any gender can participate
- Age between 18 and 75 years
- Expected survival time of at least 3 months
- Confirmed head and neck squamous cell carcinoma in oral cavity, oropharynx, hypopharynx, or larynx
- Agree to provide archived or fresh tumor tissue samples
- Have at least one measurable tumor lesion per RECIST v1.1
- ECOG performance status score of 1 or less
- Recovery from prior anti-tumor therapy toxicities to Grade 1 or less
- No severe heart dysfunction, with left ventricular ejection fraction (LVEF) 50% or higher
- Meet required organ function levels
- Coagulation function: INR 1.5 or less, APTT 1.5 times upper limit of normal or less
- Urine protein level 1+ or less, or 1000 mg/24h or less
- Use effective contraception if of childbearing potential; females must have negative pregnancy test within 7 days before first dose
You will not qualify if you...
- Squamous cell carcinoma originating from nasopharynx, salivary glands, nasal sinuses, skin, or unknown primary site
- For Phase II, patients suitable for or willing to have local therapy, or who received prior systemic chemotherapy except multimodal treatment for locally advanced disease
- Central nervous system metastases, carcinomatous meningitis, or spinal cord compression
- Participation in another clinical trial within 4 weeks before study drug
- Chemotherapy, radiotherapy, biological, endocrine, immunotherapy, or other antitumor treatments within 4 weeks before first dose
- Major surgery within 4 weeks prior to first dose
- Need for systemic corticosteroids or immunosuppressive therapy within 2 weeks before study drug
- Pulmonary disease grade 3 or higher, or history of interstitial lung disease
- Active infection needing intravenous anti-infective therapy
- Prior immunotherapy causing grade 3 or higher immune-related adverse events or grade 2 or higher myocarditis
- Use of live vaccines within 4 weeks before first dose
- Use of immunomodulatory drugs within 14 days before first dose
- Risk or history of active autoimmune diseases
- Other cancer within 5 years before first dose
- Positive for HIV, active tuberculosis, hepatitis B or C infection
- Poorly controlled high blood pressure
- History of severe cardiovascular or cerebrovascular disease
- Prior stem cell, bone marrow, or organ transplant
- Significant or uncontrolled serous cavity effusion
- History of severe allergic reaction to study drugs
- History of severe infusion reactions to antibody therapy
- History of stem cell transplantation
- Pregnant or breastfeeding women
- Any condition making participation unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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