Phase II Study of HLX43 Drug for Recurrent or Metastatic Nasopharyngeal Carcinoma After Second-line Therapy Failure or Intolerance

What this Trial Is About

Researchers are evaluating HLX43, an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor, in patients with recurrent or metastatic Nasopharyngeal Carcinoma NPC who have not responded to or cannot tolerate second-line therapies. This phase II open-label study aims to find the appropriate dose and assess the safety, tolerability, and effectiveness of HLX43 in this patient group. Participants are randomly assigned to one of three HLX43 dose groups. The drug is given through intravenous infusion every three weeks. Treatment continues as long as patients tolerate it well and the disease remains controlled, stopping only if the disease progresses, intolerable side effects occur, another anti-cancer therapy is started, consent is withdrawn, or death occurs. During the study, patients will undergo regular assessments including tumor evaluations to measure response and progression, safety monitoring for adverse effects, and tissue sample collection for PD-L1 expression analysis. The main outcomes measured are the overall response rate within 24 weeks and progression-free survival up to 12 months. Patients will be followed for safety and survival for up to 18 months after treatment starts.

A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy