NCT06839066

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

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma (NPC) Failed or Intolerance to Second-line Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is to explore the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic Nasopharyngeal Carcinoma (NPC) who failed or are intolerant to second-line herapy.

Detailed description

This study is an open-label phase II clinical study to explore the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic Nasopharyngeal Carcinoma (NPC) who failed or are intolerant to second-line therapy. In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at three different doses via intravenous infusion.

Conditions

• Nasopharyngeal Carcinoma (NPC)

Interventions

Type	Name	Description
DRUG	HLX43 DOSE 1	HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
DRUG	HLX43 DOSE 2	HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
DRUG	HLX43 DOSE 3	HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

Timeline

• Start date: 2025-04-02
• Primary completion: 2026-11-22
• Completion: 2027-11-22
• First posted: 2025-02-21
• Last updated: 2025-11-24

Locations

15 sites across 1 country: China