Actively Recruiting
Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma
Led by Shanghai Institute Of Biological Products · Updated on 2026-01-16
81
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up.
CONDITIONS
Official Title
Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily consent to participate in the study
- Male or female aged 18 to 75 years
- Diagnosed with recurrent or metastatic advanced HNSCC (not nasopharyngeal carcinoma) by histology or cytology
- Disease progressed or intolerant after prior immunotherapy containing anti-PD-1/anti-PD-L1 and platinum
- Have received no more than 2 prior lines of treatment
- Provide tumor tissue and blood samples for biomarker detection, or previous qualified test reports
- Have at least one measurable lesion per RECIST v1.1 (excluding lesions in previous radiotherapy or local treatment areas unless progressing)
- ECOG performance status of 0 or 1
- Laboratory tests meet study requirements
- Expected survival of at least 3 months
- Negative pregnancy test within 7 days before first treatment for fertile females
- Agree to effective contraception during study and for 6 months after last dose if of reproductive potential
You will not qualify if you...
- Primary squamous cell carcinoma located in nasal cavity, paranasal sinuses, nasopharynx, or salivary gland
- Previous HER3 or EGFR targeted therapy
- Active central nervous system or meningeal metastasis
- Allergy to immunoglobulin or antibody preparations or serious infusion reactions
- History of other malignant tumors in past 5 years (except cured thyroid cancer, skin basal cell carcinoma, cervical carcinoma in situ)
- Active HIV, hepatitis B or C, syphilis, active tuberculosis, or asymptomatic chronic hepatitis B or C carrier
- Unresolved toxicity from prior anti-tumor therapy higher than grade 1 (except specific stable conditions)
- Participation in other research treatments or drugs within 4 weeks before study
- Planned other anti-tumor treatments during trial
- Recent major surgery, radiotherapy (except palliative), or unhealed wounds within 4 weeks
- Use of Chinese patent or herbal medicines with anti-tumor effects within 2 weeks
- Chemotherapy within 3 weeks or other anti-tumor therapies within 4 weeks before study
- Live vaccination within 30 days before study
- Active infections needing systemic treatment
- History of severe lung diseases
- Recent thromboembolism within 6 months (except infusion-related)
- Cardiovascular risk history or abnormal ECG or heart function
- Surgery within 28 days before study or expected during study (except biopsy)
- Mental disorders or poor compliance
- Pregnant or breastfeeding
- Serious accompanying diseases endangering safety or study completion
- Long-term high-dose hormone or immunosuppressive therapy
- Uncontrollable pleural, abdominal, or other effusions after active treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
2
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
D
Dandan Chen, Master
CONTACT
Y
Ye Guo, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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