Actively Recruiting
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent/Metastatic Esophageal Squamous Cell Carcinoma Failed or Intolerance to Standard First-line Therapy
Led by Shanghai Henlius Biotech · Updated on 2026-05-18
102
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HLX43, an investigational drug, in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who have not responded to or cannot tolerate standard first-line treatments. This open-label phase II study aims to determine the appropriate dose and assess the drug's effectiveness, safety, and tolerability in this patient population. The study is sponsored by Shanghai Henlius Biotech. Participants will be randomly assigned to one of four groups receiving different doses of HLX43 via intravenous infusion every three weeks. The doses under study include 2.0 mg/kg, 2.5 mg/kg, 3.0 mg/kg, and a 3.0 mg/kg loading dose. This dosing schedule will continue to evaluate the best dose for further research. Throughout the study, participants will undergo various assessments including tumor measurements based on RECIST v1.1 criteria, laboratory tests to monitor organ function, and evaluations for side effects. The primary outcomes focus on objective response rate within 24 weeks and progression-free survival up to 14 months. Secondary measures include overall survival and the incidence of adverse events observed up to 24 months. Participants will be monitored regularly during treatment and follow-up to understand the drug's impact and safety over time.
CONDITIONS
Brief 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 the Informed Consent Form
- Age between 18 and 75 years
- Confirmed diagnosis of esophageal squamous cell carcinoma by histopathology or cytology
- Advanced ESCC patients who failed or are intolerant to prior first-line standard therapy
- At least one measurable target lesion within 4 weeks before first medication
- Provide tumor tissue for PD-L1 expression evaluation if possible
- Adequate intervals from prior therapies and recovery from related adverse events
- ECOG physical performance score of 0 or 1
- Expected survival of at least 3 months
- Adequate organ function confirmed by recent laboratory tests
- Agree to use effective contraception during and for 6 months after the trial; females of childbearing potential must have a negative pregnancy test
You will not qualify if you...
- History of another malignant tumor within 2 years before randomization
- Body mass index below 17.5 kg/m2
- Symptomatic, untreated, or worsening CNS or leptomeningeal metastases
- Uncontrolled pleural, pericardial effusion or ascites needing frequent drainage
- History of severe radiation pneumonia or interstitial lung disease requiring steroids
- Poorly controlled cardiovascular symptoms or diseases
- History or preparation for organ or bone marrow transplant
- Active systemic infection requiring intravenous antibiotics within 2 weeks
- Use of strong CYP2D6 or CYP3A inhibitors or inducers within 2 weeks
- Recent systemic corticosteroid or immunosuppressive treatment with exceptions
- History of serious immune-related adverse events from immunotherapy
- Active or suspected autoimmune disease except controlled hypothyroidism or type 1 diabetes
- Recent live vaccinations within 4 weeks before dosing
- Known severe allergy to monoclonal antibodies or related drug components
- 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 researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 14 months or until disease progression or discontinuation
Participants receive HLX43 at different doses via intravenous infusion every 3 weeks.
Infusions every 3 weeks with visits for administration and monitoring
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
J
Jinming Yu, Dr.
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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