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

StatusUnknown
PhasePhase 2
Started

Record status This record was last updated June 17, 2024 (before its estimated September 30, 2024 completion). Its status may not reflect the trial's current state.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Jun 2024); last known: Active, Not Recruiting
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 30, 2024 to Sep 30, 2024
    • Site details revised
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jun 30, 2023 to Jun 30, 2024
    • Start date changed from estimate of Dec 30, 2022 to Dec 14, 2022
    • Site details revised
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT05513573
Lead Sponsor Shanghai Henlius Biotech
Conditions
(from sponsor)		 Nasopharyngeal Carcinoma by AJCC V8 Stage
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov