The study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BC3195 in patients with locally advanced or metastatic solid tumors.

BC3195 is a novel ADC targeting CDH3/P-cadherin, a calcium-dependent cell-cell adhesion glycoprotein highly expressed in a variety of malignancies, including lung, breast, gastric, ovarian, colorectal, and pancreatic cancers. CDH3 expression is low or undetectable in normal tissues, making it an ideal target for anticancer therapies, particularly ADCs.

Currently, BC3195 is the only ADC targeting CDH3 in clinical development globally. In preclinical studies, BC3195 binds to cell surface CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted tumor cells as well as surrounding cells which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and strong antitumor activity with tumor growth inhibition of ≥100%.

In addition to clinical trials being conducted in China, BC3195 has an active US IND. BioCity Biopharma expects to obtain preliminary clinical data on BC3195 by the end of 2023 from clinical trials in China as well as in the US.