Last reviewed · How we verify
HLX02
HLX02 is a monoclonal antibody that binds to and blocks the PD-1 checkpoint receptor on immune cells, allowing them to recognize and attack cancer cells.
HLX02 is a monoclonal antibody that binds to and blocks the PD-1 checkpoint receptor on immune cells, allowing them to recognize and attack cancer cells. Used for Non-small cell lung cancer, Gastric cancer, Esophageal cancer.
At a glance
| Generic name | HLX02 |
|---|---|
| Sponsor | Shanghai Henlius Biotech |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HLX02 is a humanized anti-PD-1 monoclonal antibody that prevents the interaction between PD-1 on T cells and its ligands (PD-L1/PD-L2) on tumor cells. By blocking this inhibitory checkpoint, the drug restores anti-tumor immune responses, enabling T cells to proliferate and kill cancer cells. This mechanism is similar to other approved PD-1 inhibitors and is used across multiple cancer types.
Approved indications
- Non-small cell lung cancer
- Gastric cancer
- Esophageal cancer
Common side effects
- Fatigue
- Decreased appetite
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
- Infusion-related reactions
Key clinical trials
- Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (PHASE2)
- Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (PHASE1, PHASE2)
- TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (PHASE2)
- An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (PHASE4)
- Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer (PHASE3)
- Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- HLX02 CI brief — competitive landscape report
- HLX02 updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI