Actively Recruiting
Phase IbII Study of HLX43 Combined With Serplulimab to Treat Advanced or Metastatic Solid Tumors
Led by Shanghai Henlius Biotech · Updated on 2025-11-17
105
Participants Needed
3
Research Sites
48 weeks
Total Duration
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 IbII 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
Research Team
B
Bo Zhu, Dr
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