Samsung Bioepis Co., Ltd. announced  the initiation of a Phase 1 clinical trial for SBE303, its first novel antibody drug conjugate candidate designed to target Nectin 4, an adhesion protein selectively expressed in tumour cells including urothelial, lung, and breast cancers.

The Phase 1 study is an open label, multi centre, first in human clinical trial aimed at evaluating the safety, tolerability, and preliminary efficacy of SBE303 in patients with advanced refractory solid tumours. The study marks a significant step in Samsung Bioepis’ expansion into innovative oncology therapeutics beyond its established biosimilars portfolio.

SBE303 has been engineered to selectively bind to Nectin 4, enabling targeted delivery of cytotoxic agents directly to tumour cells. By leveraging the precision of antibody drug conjugate technology, the candidate aims to enhance anti tumour activity while minimising off target effects.

The initiation of this clinical trial underscores Samsung Bioepis’ commitment to advancing novel biologics and addressing unmet medical needs in oncology, particularly for patients with limited treatment options in advanced stage cancers.

Further details of the trial are available on ClinicalTrials.gov under identifier NCT07524348.