Pilatus Biosciences has announced the dosing of the first patient in its Phase I clinical trial of PLT012, a first-in-class anti-cluster of differentiation 36 (CD36) monoclonal antibody, at Next Oncology in Houston, Texas, US.

The multi-centre, open-label trial will evaluate the antibody in patients with advanced solid tumours.

The US Food and Drug Administration (FDA) recently granted investigational new drug (IND) clearance to PLT012.

By inhibiting CD36-mediated fatty acid uptake, PLT012 is designed to activate effector cells and reduce immunosuppressive cell populations.

The study will assess the tolerability, safety, maximum tolerated dose, and the recommended Phase II dose of PLT012.

Expansion cohorts are planned for tumour types characterised by lipid-driven metabolic dysregulation such as those with liver metastases and cancers.

Secondary endpoints include biomarkers, pharmacodynamics, pharmacokinetics, and early clinical response indicators. A biomarker strategy focused on CD36 biology aims to provide translational insights and guide patient stratification for future trials.

Preclinical results showed that PLT012 blocked CD36-mediated metabolic reprogramming in regulatory T cells and CD8+ tumour-infiltrating lymphocytes, leading to increased antitumour activity.

The antibody received orphan drug designation from the FDA in December 2024 for hepatocellular carcinoma (HCC) and intrahepatic bile duct cancers. Fast track designation for HCC was granted on 14 February 2026.

Pilatus Biosciences CEO and co-founder Raven Lin said: “Dosing our first patient is an important milestone for Pilatus and validates our work advancing a new immuno-metabolic approach to cancer therapy.

“Many solid tumours create a metabolically hostile microenvironment that drives immune exhaustion and resistance to existing therapies. PLT012 is designed to directly address this metabolic suppression, with the goal of restoring effective antitumour immunity for patients with limited treatment options.”