{"entity":{"id":"ibi354","kind":"drug","name":"IBI354","aka":[],"tldr":"IBI354 is an experimental antibody-drug conjugate from Innovent Biologics (Suzhou) in phase 3 trials for HER2-positive breast cancer and ovarian cancer, aimed at HER2.","summary":"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; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of IBI354","url":"https://clinicaltrials.gov/search?intr=IBI354"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","ovarian"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07377643","nct06834672","nct05636215"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"ADC","mechanism":"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.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ibi354/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"innovent","kind":"company","name":"Innovent Biologics","route":"/companies/innovent/"}],"trial":[{"id":"nct05636215","kind":"trial","name":"A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors","route":"/trials/nct05636215/"},{"id":"nct07377643","kind":"trial","name":"IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer","route":"/trials/nct07377643/"},{"id":"nct06834672","kind":"trial","name":"Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","route":"/trials/nct06834672/"}]}}