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IBI310
IBI310 is a bispecific antibody that simultaneously engages PD-1 on T cells and TIM-3 on tumor-infiltrating lymphocytes to enhance anti-tumor immune responses.
IBI310 is a bispecific antibody that simultaneously engages PD-1 on T cells and TIM-3 on tumor-infiltrating lymphocytes to enhance anti-tumor immune responses. Used for Advanced or metastatic solid tumors (Phase 3 development).
At a glance
| Generic name | IBI310 |
|---|---|
| Also known as | CTLA-4 |
| 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
IBI310 functions as a bispecific monoclonal antibody designed to block two immune checkpoints—PD-1 and TIM-3—that are often co-expressed on exhausted T cells in the tumor microenvironment. By simultaneously targeting both pathways, the drug aims to overcome resistance to single-checkpoint inhibition and restore T cell effector function more effectively than monotherapy approaches.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Immune-related adverse events (irAEs)
- Fatigue
- Diarrhea
- Rash
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment. (PHASE2, PHASE3)
- A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC (PHASE3)
- A Prospective, Randomized Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 Treating Advanced HCC (PHASE2)
- Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer (PHASE2)
- A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and Ipilimumab（YERVOY）in Adult Healthy Chinese Male Volunteers (PHASE1)
- Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE) (PHASE2)
- IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer (PHASE2)
- Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical 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:
- IBI310 CI brief — competitive landscape report
- IBI310 updates RSS · CI watch RSS
- Innovent Biologics (Suzhou) Co. Ltd. portfolio CI