Actively Recruiting
A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors
Led by Shanghai Henlius Biotech · Updated on 2025-11-17
105
Participants Needed
3
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced/metastatic solid tumors
CONDITIONS
Official 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
- Age between 18 and 75 years
- For phase Ib, have histologically or cytologically confirmed advanced/metastatic solid tumor with prior treatment failure or no standard treatment
- For phase II, have advanced/metastatic non-small cell lung cancer with EGFR mutation and failure or intolerance to EGFR-TKI or platinum-based chemotherapy
- Have at least one measurable lesion within 4 weeks before first dose
- Provide qualified tumor tissue samples for PD-L1 expression testing
- Have ECOG performance status score of 0 or 1 within 7 days before first dose
- Expected survival of at least 12 weeks
- Normal major organ functions within 14 days before first administration without recent transfusions or growth factor treatments
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before first dose, agree to use effective contraception during the trial and for 6 months after last dose, and not breastfeed
- Male participants must agree to use effective contraception during the trial and for 6 months after last dose
You will not qualify if you...
- History of a second malignancy within 3 years except certain early-stage cancers treated radically
- Previous grade 3 or higher immune-related adverse events during immunotherapy
- Pleural, pericardial effusion, or ascites requiring clinical intervention
- Active or symptomatic brain metastases or spinal cord compression not controlled
- History or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung function impairment
- Poorly controlled cardiovascular or cerebrovascular conditions including heart failure, unstable angina, recent heart attack or stroke, uncontrolled arrhythmia, or hypertension
- History of immunodeficiency or organ transplant
- Active pulmonary tuberculosis
- Active hepatitis B, hepatitis C, or co-infection
- Known active or suspected autoimmune disease unless stable without systemic immunosuppressive therapy
- Use of systemic corticosteroids or immunosuppressants above specified doses within 14 days before first dose or during study (with some exceptions)
- Active infection needing systemic anti-infective treatment within 14 days before first dose
- Major surgery within 28 days before first dose (except minor procedures)
- Use of strong CYP2D6 or CYP3A inhibitors or inducers within 2 weeks before first dose
- Live viral vaccine within 28 days before first dose (inactivated flu or COVID-19 vaccines allowed)
- Participation in another clinical trial with less than 14 days since end of therapy or insufficient washout from prior anti-tumor therapy
- Known severe allergy to any monoclonal antibody
- Any clinical or laboratory abnormalities or other factors making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
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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