Actively Recruiting
Phase II Study Evaluating HLX43 (Anti-PD-L1 ADC) in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma Who Failed or Are Intolerant to Standard Therapy
Led by Shanghai Henlius Biotech · Updated on 2025-03-10
90
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HLX43, an anti-PD-L1 antibody-drug conjugate, in patients with locally advanced or metastatic hepatocellular carcinoma (HCC) who have failed or cannot tolerate standard treatments. This open-label phase II study aims to find the right dose and assess the drug's effectiveness, safety, and tolerability in this patient group. The trial is sponsored by Shanghai Henlius Biotech and includes adults aged 18 to 75 years. Participants will be randomly assigned to receive one of three different doses of HLX43 given by intravenous infusion every three weeks. Treatment continues until disease progression, unacceptable side effects, death, starting a new anti-cancer therapy, or withdrawal of consent. The drug combines an antibody targeting PD-L1 with a potent DNA topoisomerase I inhibitor. All groups receive the same schedule and monitoring during the study. During the study, participants undergo evaluations of tumor response using imaging based on RECIST v1.1 criteria, safety assessments, and laboratory tests. Researchers will measure objective response rate (ORR) up to 24 weeks and progression-free survival (PFS) up to 14 months. Secondary outcomes include overall survival and adverse event rates up to 36 and 24 months respectively. Participants are monitored regularly throughout treatment and follow-up until study completion or withdrawal.
CONDITIONS
Brief Title
A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC 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, any gender
- Confirmed diagnosis of hepatocellular carcinoma (HCC) or clinically meeting AASLD criteria
- Previous failure or intolerance to at least one standard systemic therapy for HCC
- BCLC stage C or BCLC stage B unsuitable for locoregional therapy
- At least one measurable target lesion per RECIST v1.1 within 4 weeks prior to first treatment
- Provide tumor tissue for PD-L1 expression evaluation if possible
- Specified intervals since last anticancer treatments and recovery from adverse events
- Child-Pugh liver function grade A within 7 days before first dose
- ECOG performance status 0-1 within one week prior to randomization
- Expected survival of at least 3 months
- Specific criteria for hepatitis B and C viral status
- Adequate organ function confirmed by lab tests within 14 days prior to first dose
- Agree to use effective contraception during study and 6 months after last dose
- Negative pregnancy test within 7 days prior to enrollment for females of childbearing potential
You will not qualify if you...
- Diagnosis of hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma
- History of second malignancy within 2 years except certain early-stage cancers
- History of hepatic encephalopathy or liver transplant
- Recent portal hypertension with bleeding risk or high bleeding risk of liver cancer nodules
- Portal vein invasion Vp4 or involvement of inferior vena cava or heart
- Uncontrollable pleural, pericardial effusion or ascites requiring frequent drainage
- Symptomatic or worsening brain or leptomeningeal metastases
- Recent major liver surgery or local liver treatments within 4 weeks
- Recent radiation therapy within specified timeframes
- History of severe lung disease affecting lung toxicity detection
- Severe allergic reactions to monoclonal antibodies or trial drug components
- Active systemic infection requiring intravenous antibiotics
- Poorly controlled cardiovascular conditions or recent heart events
- History of grade 3 or higher immune-related adverse events from prior immunotherapy
- Active or suspected autoimmune disease except controlled hypothyroidism or type 1 diabetes
- Recent systemic corticosteroid or immunosuppressive treatment except certain exceptions
- Live or attenuated vaccines within 4 weeks prior to dosing
- Recent use of strong CYP2D6 or CYP3A inhibitors or inducers
- Active tuberculosis or HIV infection
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive HLX43 drug treatment via intravenous infusion once every 3 weeks. Treatment continues until disease progression, start of new anti-tumor therapy, intolerable side effects, withdrawal, or death.
Infusion visits every 3 weeks
Duration - Up to approximately 36 months after randomization
Participants are monitored after treatment ends for survival and safety outcomes.
Visits scheduled based on study follow-up assessments
Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Hunan, Hunan, China, 410013
Actively Recruiting
Research Team
H
Hua Xiang, Dr.
S
Shanzhi Gu, Dr
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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