Actively Recruiting
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Led by Shanghai Henlius Biotech · Updated on 2026-03-05
167
Participants Needed
2
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
CONDITIONS
Official Title
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and agree to participate by signing informed consent
- Aged 18 to 75 years, male or female
- Have recurrent or metastatic head and neck squamous cell carcinoma confirmed by biopsy
- For cohort 1: refractory to prior systemic treatment
- For cohort 2: no prior systemic therapy for recurrent/metastatic disease and no progression within 6 months after prior treatment for locally advanced disease
- Have at least one measurable tumor lesion within 4 weeks before randomization
- Agree to provide archived tumor tissue or undergo biopsy
- Completed prior treatments with appropriate waiting periods and recovered from related side effects
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 1 week before randomization
- Life expectancy greater than 3 months
- Adequate organ function per recent lab tests
- Agree to use effective contraception during the study and for at least 6 months after final dose; females of childbearing potential must have a negative pregnancy test within 7 days before enrollment
You will not qualify if you...
- Eligible for locoregional radical treatment for head and neck tumor
- Diagnosed with primary nasopharyngeal carcinoma
- Tumor invading or surrounding large blood vessels in chest, neck, or pharynx with bleeding risk
- History of second cancer within 2 years before randomization
- Previous severe immune-related side effects from immunotherapy
- Uncontrolled pleural, pericardial effusions, or ascites requiring repeated drainage
- Newly diagnosed or symptomatic brain or spinal metastases or cancerous meningitis
- Prior or current lung diseases that may interfere with treatment or assessments
- Poorly controlled heart or brain vascular conditions
- Active infections requiring IV antibiotics within 2 weeks before randomization
- Use of strong CYP2D6 or CYP3A drugs within 2 weeks before randomization
- Recent systemic corticosteroids or immunosuppressants within 2 weeks before randomization
- Known active or suspected autoimmune diseases
- Recent live vaccines within 4 weeks before randomization
- Severe allergy to monoclonal antibodies or investigational product components
- Active tuberculosis
- Immunodeficiency or history of organ transplant
- Active hepatitis B or C infection
- Pregnant or breastfeeding women
- Any condition making the participant unsuitable as judged by the investigator
- Prior treatment with drugs targeting topoisomerase I
- Radiation therapy within 3 months before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, China, 250117
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
C
Chaosu Hu, Dr
CONTACT
M
Man Hu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here