Actively Recruiting
Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Led by Shanghai Henlius Biotech · Updated on 2025-11-18
60
Participants Needed
1
Research Sites
158 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 Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
CONDITIONS
Official Title
Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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, any gender
- Confirmed advanced gastric or gastroesophageal junction adenocarcinoma by tissue examination
- Disease progressed or intolerant after at least one prior standard systemic treatment, or not suitable for radical treatment
- At least one measurable tumor lesion within 4 weeks before randomization
- Willing to provide tumor tissue for PD-L1 testing either from archived samples or new biopsy
- Sufficient recovery time from previous therapies before starting study treatment
- ECOG performance status of 0 or 1 within 1 week before randomization
- Life expectancy greater than 3 months
- Adequate organ function confirmed by recent lab tests
- Agree to use effective contraception during the study and for 6 months after last dose; females of childbearing potential must have a negative pregnancy test before enrollment
You will not qualify if you...
- Previous treatment with topoisomerase I targeting drugs including chemotherapy and ADC
- Radical radiation therapy within 3 months before first dose
- History of second malignancy within 2 years except certain early-stage cancers with radical treatment
- Past severe immune therapy side effects or immune-related pneumonitis/myocarditis grade 2 or higher
- Uncontrolled pleural, pericardial effusion or ascites requiring repeated drainage
- Active gastrointestinal bleeding grade 2 or higher
- Spinal cord compression or active brain metastases needing corticosteroids or anticonvulsants
- Significant lung diseases or autoimmune diseases affecting lungs
- Poorly controlled heart or vascular diseases including heart failure, unstable angina, recent heart attack or stroke, arrhythmias, or high blood pressure
- Active infections needing IV antibiotics or recent tuberculosis
- Recent use of strong CYP2D6 or CYP3A modulators
- Recent systemic corticosteroid or immunosuppressant use except certain topical or short-term uses
- Known active or suspected autoimmune diseases except controlled hypothyroidism and type 1 diabetes
- Live vaccine use within 4 weeks prior to randomization
- Known allergies to monoclonal antibodies or study drug components
- History of immunodeficiency including HIV or organ transplantation
- Active hepatitis B or C infections
- Pregnant or breastfeeding women
- Any other medical or lab abnormalities judged by investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
L
Liya Wan
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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