IBI354

IBI354 is an antibody-drug conjugate developed by Innovent Biologics (Suzhou) and Innovent Biopharmaceutical Technology (Hangzhou). Its target is HER2 (the sponsor names HER2). The sponsor states: IBI354 is a HER2-targeting antibody-drug conjugate (ADC), given as a 12 mg/kg IV infusion every three weeks, studied versus investigator's choice of chemotherapy in HER2-expressing tumours. ClinicalTrials.gov describes the intervention as: Recombinant Anti-HER2 monoclonal Antibody-Camptothecin derivative conjugate for injection. It is the investigational product in 3 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT07377643 (IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer) and NCT06834672 (Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer), in HER2-positive breast cancer and ovarian cancer. The largest, NCT07377643, plans to enrol 540 participants with primary completion expected 2028-04-28. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.