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IBI354 + pertuzumab
- Development stage
- Phase 3
- Lead developer
- Innovent Biologics
- Modality
- Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intravenous
01
Overview
IBI354 + pertuzumab is an investigational combination regimen consisting of IBI354, a next-generation HER2-targeted antibody-drug conjugate (ADC), and pertuzumab, a HER2-targeted monoclonal antibody. Developed by Innovent Biologics, IBI354 is built on the proprietary SoloTx ADC platform and comprises a trastuzumab-based anti-HER2 antibody conjugated to a camptothecin-derivative topoisomerase I inhibitor payload via a hydrophilic linker, achieving a drug-to-antibody ratio (DAR) of 8. Pertuzumab binds to a distinct domain of HER2 (domain II) compared to trastuzumab (domain IV), providing complementary HER2 blockade. The combination is currently being evaluated in the Phase 3 HeriCare-Breast01 trial (NCT07377643) as a first-line treatment for patients with HER2-positive, unresectable locally advanced or metastatic breast cancer, where it has demonstrated encouraging antitumor activity and a favorable safety profile with low rates of interstitial lung disease.
- Other names
- IBI354 and pertuzumabIBI-354 and pertuzumabIBI 354 and pertuzumabIBI354 plus pertuzumabIBI-354 plus pertuzumabIBI 354 plus pertuzumabpertuzumab + IBI354
02
Targets
NeuraminidaseFcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)ERBB2 (Erb-b2 receptor tyrosine kinase 2)
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