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IBI363
IBI363 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TIM-3 on T cells to enhance anti-tumor immune responses.
IBI363 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TIM-3 on T cells to enhance anti-tumor immune responses. Used for Advanced or metastatic solid tumors (Phase 3 development).
At a glance
| Generic name | IBI363 |
|---|---|
| Also known as | IBI325, Lenvatinib, No other name |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Drug class | Bispecific checkpoint inhibitor |
| Target | PD-1 and TIM-3 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
IBI363 functions as a bispecific monoclonal antibody designed to block two immune checkpoint pathways simultaneously. By targeting both PD-1 and TIM-3, the drug aims to overcome resistance mechanisms that allow tumors to evade immune surveillance, thereby enhancing T cell activation and proliferation against cancer cells.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Immune-related adverse events (irAEs)
- Fatigue
- Diarrhea
- Rash
Key clinical trials
- IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed (PHASE3)
- A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas (PHASE1)
- IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer (PHASE2)
- IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer (PHASE2)
- IBI363 Plus Bevacizumab With or Without Nab-Paclitaxel for Second-Line Treatment of Advanced Gastric Cancer (PHASE1, PHASE2)
- Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer (PHASE1, PHASE2)
- Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer (PHASE2)
- Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2) (PHASE1, 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:
- IBI363 CI brief — competitive landscape report
- IBI363 updates RSS · CI watch RSS
- Innovent Biologics (Suzhou) Co. Ltd. portfolio CI