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IBI343
IBI343 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TGF-β in the tumor microenvironment to enhance anti-tumor immunity.
IBI343 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 | IBI343 |
|---|---|
| Also known as | Arcotatug Tavatecan, AG regimen |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Drug class | Bispecific antibody; PD-1/TGF-β inhibitor |
| Target | PD-1 and TGF-β |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
IBI343 functions as a PD-1/TGF-β bispecific antibody designed to overcome immunosuppression in the tumor microenvironment. By blocking PD-1 signaling while simultaneously neutralizing TGF-β, the drug aims to reinvigorate exhausted T cells and reduce the immunosuppressive effects of TGF-β, thereby enhancing anti-tumor immune responses.
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
- IBI343 in Combination Therapy for Advanced Malignant Solid Tumors (PHASE2)
- IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (PHASE2)
- IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer (PHASE2)
- A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (PHASE1)
- IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer (PHASE2)
- A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (PHASE3)
- A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002) (PHASE3)
- IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer (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 |