Actively Recruiting
A Phase Ib/II Clinical Study to Evaluate Safety, Tolerability, and Efficacy of HLX43 (Anti-PD-L1 ADC) Combined With Serplulimab (Anti-PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors
Led by Shanghai Henlius Biotech · Updated on 2025-11-17
105
Participants Needed
3
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying HLX43 (an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor) combined with Serplulimab (an anti-PD-1 antibody injection) in patients with advanced or metastatic solid tumors, including non-small cell lung cancer. This open-label phase Ib/II clinical trial aims to find the right dosage and assess the safety, tolerability, and effectiveness of this combination treatment. The study has two parts: phase Ib for dose escalation and phase II for dose expansion. Participants will receive different doses of HLX43 plus a fixed 300 mg dose of Serplulimab by intravenous infusion every three weeks. Those with good tolerance and disease control will continue treatment every three weeks until disease progression, intolerable side effects, new anti-tumor therapy start, death, or consent withdrawal. Participants will undergo regular assessments including tumor measurements by RECIST 1.1, PD-L1 expression testing from tumor samples, and monitoring of adverse events. Researchers will evaluate dose-limiting toxicity within 21 days after the first dose, maximum tolerated dose over about 12 months, and overall response rate up to 24 weeks. They will also track survival, disease progression, and safety outcomes throughout the study, which may last over two years.
CONDITIONS
Brief Title
A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Aged 18 to 75 years at enrollment
- Advanced or metastatic solid tumor with treatment failure or no standard treatment available (Phase Ib) or advanced/metastatic NSCLC with EGFR mutation and prior treatment failure (Phase II)
- At least one measurable tumor lesion within 4 weeks before first dose
- Provide tumor tissue for PD-L1 expression testing
- ECOG performance status of 0 or 1 within 7 days before first treatment
- Expected survival of at least 12 weeks
- Normal major organ functions without recent transfusions or growth factor treatments
- Female participants of childbearing potential must have negative pregnancy test and agree to effective contraception during and 6 months after study; breastfeeding prohibited
- Male participants must agree to effective contraception during and 6 months after study
You will not qualify if you...
- History of a second malignancy within 3 years except certain early-stage cancers treated radically
- Prior grade 3 or higher immune-related adverse events from immunotherapy
- Pleural, pericardial effusion, or ascites requiring intervention
- Uncontrolled brain or spinal metastases with symptoms
- History or current lung diseases that interfere with pulmonary toxicity assessment
- Poorly controlled cardiovascular or cerebrovascular diseases
- Immunodeficiency or organ transplant history
- Active pulmonary tuberculosis
- Active hepatitis B or C infection
- Known active or suspected autoimmune diseases unless stable without immunosuppression
- Recent systemic corticosteroid or immunosuppressive drug use above allowed doses
- Active infections requiring systemic treatment
- Major surgery within 28 days before first dose
- Use of strong CYP2D6 or CYP3A modulators within 2 weeks before dosing
- Recent live viral vaccine within 28 days, except inactivated flu or COVID vaccines
- Participation in another clinical trial or recent anti-tumor therapy within specified timeframes
- Known severe allergy to monoclonal antibodies
- Any other clinical or laboratory abnormalities making participation unsuitable as assessed by investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive HLX43 combined with Serplulimab via intravenous infusion every 3 weeks. Treatment continues until disease progression, start of new anti-tumor therapy, intolerable toxicity, withdrawal, or death.
Visits every 3 weeks for treatment infusions
Trial Site Locations
Total: 3 locations
1
Hunan Provincial Cancer Hospital
Hunan, Changsha, China, 410031
Actively Recruiting
2
Shandong Cancer Hospital
Jinan, Shangdong, China
Actively Recruiting
3
Second Affiliated Hospital of Army Medical University, PLA
Chongqing, China, 400000
Actively Recruiting
Research Team
B
Bo Zhu, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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