Trials / Active Not Recruiting
Active Not RecruitingNCT05513573
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
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)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Shanghai Henlius Biotech · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HLX07 | 1500 mg, D1，Q3W |
| DRUG | HLX10 | 300 mg, D1, up to 2 years,Q3W |
| DRUG | placebo | 1500 mg, D1，Q3W |
| DRUG | chemotherapy | gemcitabine 1000 mg/m2, D1,D8; cisplatin 80 mg/m2,D1；Q3W, up to 6 cycles |
Timeline
- Start date
- 2022-12-14
- Primary completion
- 2024-09-30
- Completion
- 2026-09-30
- First posted
- 2022-08-24
- Last updated
- 2024-06-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05513573. Inclusion in this directory is not an endorsement.