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IBI354
IBI354 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TGF-β in the tumor microenvironment to enhance anti-tumor immunity.
IBI354 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TGF-β in the tumor microenvironment to enhance anti-tumor immunity. Used for Non-small cell lung cancer, Other solid tumors (in development).
At a glance
| Generic name | IBI354 |
|---|---|
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Drug class | Bispecific antibody; PD-1/TGF-β inhibitor |
| Target | PD-1 and TGF-β |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By blocking PD-1, IBI354 relieves the inhibitory signal that tumors use to suppress T cell activation. Simultaneously, by neutralizing TGF-β, it reduces immunosuppressive signaling in the tumor microenvironment, thereby promoting a more robust anti-tumor immune response. This dual mechanism aims to overcome resistance to single-agent checkpoint inhibition.
Approved indications
- Non-small cell lung cancer
- Other solid tumors (in development)
Common side effects
- Immune-related adverse events (irAEs)
- Fatigue
- Infusion reactions
Key clinical trials
- IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (PHASE3)
- Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (PHASE3)
- A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors (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 |