Last reviewed · How we verify
KN046
KN046 is a bispecific antibody that simultaneously engages PD-L1 on tumor cells and 4-1BB on T cells to enhance anti-tumor immune responses.
KN046 is a bispecific antibody that simultaneously engages PD-L1 on tumor cells and 4-1BB on T cells to enhance anti-tumor immune responses. Used for Advanced or metastatic non-small cell lung cancer, Other solid tumors (in clinical development).
At a glance
| Generic name | KN046 |
|---|---|
| Also known as | Cisplatin+paclitaxel, Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection |
| Sponsor | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
| Drug class | Bispecific antibody; PD-L1/4-1BB bispecific immune checkpoint modulator |
| Target | PD-L1 and 4-1BB |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
KN046 functions as a PD-L1/4-1BB bispecific antibody that bridges tumor cells expressing PD-L1 with T cells expressing 4-1BB. By blocking the PD-L1/PD-1 inhibitory axis while providing costimulatory 4-1BB signaling, it aims to overcome immune checkpoint suppression and amplify T cell activation and proliferation. This dual mechanism is designed to generate stronger anti-tumor immunity compared to single-agent checkpoint inhibitors.
Approved indications
- Advanced or metastatic non-small cell lung cancer
- Other solid tumors (in clinical development)
Common side effects
- Immune-related adverse events (irAEs)
- Fatigue
- Infusion reactions
- Elevated liver enzymes
Key clinical trials
- IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer (PHASE1, PHASE2)
- TATE and KN046 in MCRC (PHASE2)
- The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma (PHASE2)
- Surufatinib Combined With KN046 and AG Regimen Chemotherapy as First-Line Treatment for Unresectable Advanced Pancreatic Cancer (PHASE1, PHASE2)
- Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC (PHASE2)
- Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer (PHASE2)
- A Study of KN046 in Patients With Thymic Carcinoma Who Failed Immune Checkpoint Inhibitors (PHASE2)
- KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor (PHASE1)
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:
- KN046 CI brief — competitive landscape report
- KN046 updates RSS · CI watch RSS
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd portfolio CI