Actively Recruiting
A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy
Led by Shanghai Henlius Biotech · Updated on 2026-01-13
72
Participants Needed
1
Research Sites
122 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 Esophageal Squamous Cell Carcinomar (ESCC) Failed or Intolerance to Standard First-Line Therapy.
CONDITIONS
Official Title
A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and sign informed consent
- Age between 18 and 75 years
- Histopathology or cytology confirmed Esophageal Squamous Cell Carcinoma
- Advanced ESCC failed or intolerant to prior first-line standard therapy
- At least one measurable target lesion within 4 weeks before first dose
- Provide tumor tissue for PD-L1 expression evaluation if possible
- At least 3 weeks or 5 half-lives interval from last cytotoxic, immuno, or biological therapy before study drug
- ECOG performance score 0-1 within one week before randomization
- Expected survival of 3 months or more
- Adequate organ function confirmed by lab tests within one week before first dose
- Agree to use effective contraception during and 6 months after study; negative pregnancy test for women of childbearing potential
You will not qualify if you...
- History of any second malignant tumor within 2 years before randomization
- Body mass index less than 17.5 kg/m2
- Symptomatic, untreated, or worsening CNS or leptomeningeal metastases
- Uncontrollable pleural, pericardial effusion, or ascites requiring frequent drainage
- History of grade 3 or higher radiation pneumonia or interstitial lung disease requiring steroids
- Poorly controlled cardiovascular conditions including heart failure, unstable angina, recent heart attack or stroke, arrhythmias, or hypertension
- Organ or bone marrow transplant recipients
- Active systemic infection needing intravenous antibiotics within 2 weeks before randomization
- Use of strong CYP2D6 or CYP3A inhibitors or inducers within 2 weeks before randomization
- Recent systemic corticosteroids or immunosuppressive treatments within 14 days before first dose with some exceptions
- History of severe immune-related adverse events or pneumonitis/myocarditis grade 2 or higher
- Active or suspected autoimmune disease except controlled hypothyroidism or type 1 diabetes
- Live vaccinations within 4 weeks before first dose except seasonal influenza vaccine
- Known severe allergy to monoclonal antibodies or components of study drug
- Previous treatment with antibody-drug conjugates using topoisomerase I inhibitors
- Active tuberculosis or HIV infection
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
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
3
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