China-based BioCity Biopharmaceutics Co., Ltd. announced a clinical collaboration agreement with US-based giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK). The partnership will initiate a global Phase I/II study to evaluate the safety and efficacy of BioCity’s BC3195 in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) for patients with locally advanced or metastatic solid tumors.
Study Design and Patient Enrollment
The study is slated to commence patient enrollment in the fourth quarter of 2025. It will assess the combination therapy’s safety and efficacy in patients with locally advanced or metastatic solid tumors. Both BioCity and MSD will retain all commercial rights to their respective compounds.
Drug Profile and Mechanism
BC3195 is a next-generation CDH3-targeted antibody drug conjugate (ADC) featuring a clinically validated, cleavable linker and payload (vc-MMAE). This design enables the destruction of targeted cancer cells as well as surrounding cells through the bystander effect. Preclinical studies have demonstrated excellent tumor-inhibiting activity, with tumor growth inhibition reaching ≥100% in some animals with well-established cancers.
Development Status
A concurrent Phase I dose optimization and dose expansion study for BC3195 is well underway in China and the US, underscoring the drug’s promising potential in oncology.-Fineline Info & Tech
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