BigHat Biosciences has dosed the patient in a Phase I clinical trial of BHB810, an antibody-drug conjugate targeting Cadherin-17 (CDH17), for the treatment of gastric cancer and other advanced gastrointestinal (GI) malignancies.
The trial will initially administer BHB810, designed using BigHat Biosciences’ AI platform, to patients with advanced gastric and gastroesophageal tumours.
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The study’s main objectives are to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of the drug candidate. Enrolment will initially focus on individuals whose tumours show CDH17 expression.
BHB810 was developed as a VHH-Fc antibody-drug conjugate. Preclinical work has covered nearly 30 patient-derived and cell-derived tumour models, including those with low and heterogeneous CDH17 expression.
The company stated that BHB810 induced complete or near-complete tumour clearance in these preclinical models.
The compact antibody structure and stable payload technology of BHB810 also reportedly contributed to a promising safety profile in animal studies.
BigHat Biosciences co-founder and CEO Peyton Greenside said: “The treatment of the first patient with BHB810 marks an important step forward in our mission to enable transformative AI-designed therapeutics and comes during a period of steady momentum for BigHat, as we continue to advance both our pipeline of novel therapeutics and AI platform.
“This is the first programme we’ve taken from AI-generated design into human studies, validating the ability of our platform to identify and develop promising antibodies into clinic-ready therapeutics.
“BHB810 could offer a differentiated approach to address a target that has been difficult to drug well, and we are excited by the potential to offer a much-needed new treatment option for patients living with GI cancers.”
In addition to BHB810, BigHat is progressing other investigational therapies. BHB299, a T-cell engager targeting CEACAM6 in solid tumours, is expected to enter clinical studies in 2027.
The company has also created antibody therapeutics in collaboration with pharmaceutical companies, including Johnson & Johnson and Merck (MSD).
In April 2025, Eli Lilly signed a new research deal with BigHat to co-develop next-generation antibody therapeutics, as the pharma company continues to expand its capabilities in AI-driven drug development.
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