Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Thursday that the first participant has been successfully dosed in the pivotal Phase 3 clinical study (HeriCare-Breast01) of IBI354.
The trial is evaluating Innovent's IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) as a first-line treatment for patients with unresectable locally advanced or metastatic HER2-positive breast cancer. IBI354 has two pivotal Phase 3 trials ongoing (HeriCare-Ovarian01 and HeriCare-Breast01), with the potential to deliver a new generation of ADC therapies characterised by high potency and low toxicity.
HeriCare-Breast01 is a multicentre, randomised, open-label, active-controlled study designed to evaluate the safety and efficacy of IBI354, with or without pertuzumab, compared with the current standard-of-care, paclitaxel plus trastuzumab and pertuzumab (THP). The primary endpoint is progression-free survival.
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