San Mateo, California-based BigHat Biosciences has dosed its first patient with BHB810, a cadherin-17 (CDH17)-directed antibody-drug conjugate (ADC) for advanced gastric and gastrointestinal (GI) cancers — marking the first human study to emerge from the company's AI-driven antibody design platform.
The Phase I, open-label, multicenter dose escalation and expansion study will initially enroll patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma, with a primary focus on safety, tolerability, pharmacokinetics, and preliminary antitumor activity. The trial anticipates enrolling patients with broader advanced GI malignancies.
BHB810 uses a VHH-Fc antibody format — a compact nanobody-based scaffold — to deliver a cytotoxic payload to CDH17-expressing tumor cells. CDH17 is a cell-surface adhesion molecule expressed across a broad range of GI cancers, including gastric, colorectal, and pancreatic tumors. No CDH17-directed therapy is currently approved.
The preclinical rationale is notable for its breadth: BigHat reports complete or near-complete tumor clearance across nearly 30 patient- and cell-derived tumor models, including gastric cancers with low and heterogeneous CDH17 expression. The company said the compact antibody format and stable payload technology produced a favorable preclinical safety profile.