drugset
drugset / Trial / NCT05513573

Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC

NCT05513573 ↗

Phase 2 Active not recruiting 75 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Timeline

Start
2022-12-14
Primary completion
2024-09-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject PIMURUTAMAB Monoclonal antibody 1500 mg —
Background Cisplatin Other / unclassified 80 mg/m2 —
Background Gemcitabine Small molecule 1000 mg/m2 —
Background Serplulimab Monoclonal antibody 300 mg —

Indications

nasopharyngeal carcinoma