Actively Recruiting
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors
Led by Shanghai Henlius Biotech · Updated on 2026-04-22
190
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic cervical cancer or ovarian cancer failed or intolerance to standard first-line therapy.
CONDITIONS
Official Title
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers willing to participate, who understand the study and can complete all procedures
- Age between 18 and 75 years old
- Cohort 1: Metastatic or recurrent cervical cancer confirmed by pathology
- Cohort 2: High-grade serous ovarian, fallopian tube, or primary peritoneal cancer confirmed by pathology
- For cervical cancer: previous failure or intolerance to standard systemic therapy including platinum-based chemotherapy and immune checkpoint inhibitors if PD-L1 positive
- For ovarian cancer: platinum-resistant disease defined by specific criteria related to prior chemotherapy and tumor progression
- At least one measurable target lesion evaluated within 4 weeks before treatment
- Tumor tissue available for PD-L1 expression testing at screening
- Sufficient interval since prior therapies (minimum weeks depending on type) and recovery from treatment adverse events
- ECOG performance status of 0-1 within one week before randomization
- Expected survival of at least 3 months
- Adequate organ function confirmed by lab tests within one week prior to first dose
- Female participants of childbearing potential must use effective contraception and have a negative pregnancy test within 7 days prior to enrollment
You will not qualify if you...
- History of second malignant tumor within 2 years prior to randomization
- Preparing for or having had organ or bone marrow transplant
- Symptomatic, untreated, or worsening CNS or leptomeningeal metastases
- Uncontrollable pleural, pericardial effusion, or ascites requiring frequent drainage
- Grade 1 or higher radiation pneumonia or suspected/interstitial lung disease
- Poorly controlled cardiovascular conditions including heart failure, unstable angina, recent heart attack or stroke, uncontrolled arrhythmias, or hypertension
- Previous severe immune-related adverse events from immunotherapy
- Active or suspected autoimmune diseases except controlled hypothyroidism or type 1 diabetes
- Recent use of systemic corticosteroids or immunosuppressants except for limited exceptions
- Active systemic infections requiring IV antibiotics within 2 weeks prior to randomization
- Recent live vaccinations within 4 weeks before dosing
- Recent use of strong CYP2D6 or CYP3A inhibitors or inducers
- Known severe allergies to monoclonal antibodies or trial drug components
- Previous treatment with ADC drugs containing topoisomerase I inhibitors
- Active tuberculosis, HIV, or active Hepatitis B or C infections
- Pregnant or breastfeeding women
- Any other factors deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital
Ji'nan, Shandong, China
Actively Recruiting
Research Team
J
Jinming Yu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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