IBI354 is an investigational anti-HER2 antibody-drug conjugate (ADC) that links a HER2-directed monoclonal antibody to a camptothecin-derivative payload. It is being studied across HER2-positive advanced solid tumors, including breast and ovarian settings, with ongoing pivotal Phase 3 development. Current public materials describe it as unapproved.
AIM ImmunoTech partners with Thermo Fisher to design Phase 3 trial for Ampligen in pancreatic cancer, while Innovent Biologics begins dosing patients in Phase 3 study of IBI354 for HER2-positive breast cancer.
Innovent Biologics has dosed the first participant in its pivotal Phase 3 HeriCare-Breast01 study evaluating IBI354, a HER2-targeted antibody-drug conjugate, as first-line treatment for unresectable locally advanced or metastatic HER2-positive breast cancer.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07377643 |
IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer |
RECRUITING | PHASE3 |
| NCT06834672 |
Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
RECRUITING | PHASE3 |
| NCT05636215 |
A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
