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 Colorectal Cancer
Led by Shanghai Henlius Biotech · Updated on 2025-11-17
60
Participants Needed
2
Research Sites
102 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 Colorectal Cancer (CRC)
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 Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and possible side effects, sign consent, and agree to participate
- Aged 18 to 75 years, any gender
- Confirmed advanced colorectal cancer by tissue tests
- Cancer progressed after at least one standard systemic treatment, or cannot have standard treatment due to toxicity or contraindications
- At least one measurable tumor lesion within 4 weeks before randomization
- Agree to provide tumor tissue sample or undergo biopsy for PD-L1 testing
- Sufficient time since prior treatments (surgery, radiotherapy, chemotherapy, immunotherapy, hormone therapy, traditional Chinese medicine) with recovery from side effects to Grade 1 or better
- ECOG performance status score 0-1 within 1 week before randomization
- Life expectancy over 3 months
- Adequate organ function confirmed by lab tests within 1 week before randomization
- Use effective contraception during study and for 6 months after last dose; females of childbearing age must have negative pregnancy test within 7 days before enrollment
You will not qualify if you...
- Radiation therapy within 3 months before first dose
- Second cancers within 2 years except certain early-stage treated cancers
- Previous severe immune-related side effects or stopping immunotherapy due to adverse events
- Uncontrolled pleural, pericardial effusions, or ascites needing repeated drainage
- Active significant gastrointestinal bleeding
- Spinal cord compression or active brain metastases requiring symptom control treatments
- Serious lung diseases or past lung damage affecting safety
- Poorly controlled heart or cerebrovascular disease including heart failure, unstable angina, recent heart attack or stroke, arrhythmias, or uncontrolled hypertension
- Active infections needing IV antibiotics or active tuberculosis within 2 weeks
- Use of certain enzyme inhibitors or inducers within 2 weeks
- Recent use of systemic corticosteroids or immunosuppressants within 2 weeks except certain forms
- Known active or suspected autoimmune diseases except controlled hypothyroidism or type 1 diabetes
- Live vaccines within 4 weeks
- Allergy to monoclonal antibodies or study drug components
- History of immunodeficiency or organ transplant
- Active hepatitis B or C infection
- Pregnant or breastfeeding
- Any other clinical or lab reason deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
2
Jinan First People's Hospital
Jinan, China
Actively Recruiting
Research Team
L
Liya Wan
CONTACT
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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