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HLX10
HLX10 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.
HLX10 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses. Used for Non-small cell lung cancer, Gastric cancer, Esophageal cancer.
At a glance
| Generic name | HLX10 |
|---|---|
| Also known as | Recombinant humanized anti-PD-1 monoclonal antibody injection, Serplulimab, Anti-PD-1 Humanized Monoclonal Antibody, SERPLULIMAB, anti-PD-1 monoclonal antibody |
| Sponsor | Shanghai Henlius Biotech |
| Drug class | PD-L1 inhibitor |
| Target | PD-L1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HLX10 targets programmed death ligand 1 (PD-L1) on tumor cells and immune cells, preventing the PD-L1/PD-1 interaction that normally suppresses T-cell activation. By blocking this immune checkpoint, the drug allows cytotoxic T lymphocytes to recognize and attack cancer cells more effectively. This mechanism is used across multiple solid tumors where PD-L1 expression is associated with immune evasion.
Approved indications
- Non-small cell lung cancer
- Gastric cancer
- Esophageal cancer
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
Key clinical trials
- Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer. (PHASE2)
- Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC (PHASE2)
- Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer (PHASE2)
- A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (PHASE2)
- A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in High-Risk Locally Advanced Rectal Cancer (PHASE3)
- A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC (PHASE2)
- A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study (PHASE2)
- A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |