Pilatus Biosciences has dosed the first patient in Hong Kong, as part of an ongoing Phase I clinical trial assessing PLT012, an investigational therapy for hepatocellular carcinoma (HCC).
The administration occurred within the biomarker backfill cohort, which enrols individuals diagnosed with advanced HCC, including patients presenting with underlying liver dysfunction.
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The Chinese University of Hong Kong is conducting the study at the Phase I Clinical Trial Centre within its Department of Clinical Oncology, following trial authorisation from the Hong Kong Department of Health in July 2026.
The site will support both backfill and dose-expansion cohorts, collecting biomarker data and assessing early clinical activity.
The trial intends to use the combined clinical and biological findings to guide the future clinical development of PLT012 across chronic liver dysfunction and malignant disease.
Pilatus Biosciences CEO and co-founder Raven Lin said: “Dosing the first patient in Hong Kong represents an important milestone for the PLT012 programme and for Pilatus as we continue expanding the global clinical development of our lead programme.
“By collecting clinical and biomarker data from patients with HCC, we aim to better understand PLT012’s broader anti-tumour activity, inform its next stage of development supported by FDA fast track designation, and further explore mechanisms associated with response to immunotherapy in HCC.”
The therapy is a humanised monoclonal antibody targeting cluster of differentiation 36 (CD36), which regulates lipid uptake inside the tumour microenvironment.
By blocking this uptake, PLT012 is intended to reduce populations of immunosuppressive cells, including regulatory T cells and pro-tumour macrophages, whilst restoring the function of cytotoxic CD8+ T cells and natural killer cells affected by lipid-driven exhaustion.
In preclinical testing across species, the candidate demonstrated monotherapy activity in liver malignancy models with a favourable safety profile, as well as sensitising effects alongside other oncology treatments in liver metastases and immune cold tumours.
Pilatus was established in 2022 out of the Ludwig Institute for Cancer Research, with support from the Cancer Research Institute, and maintains research teams in Taiwan and Switzerland.
The company launched a Hong Kong subsidiary earlier this year to use local clinical research infrastructure for PLT012 and to develop further academic and strategic collaborations in metabolic checkpoint immunotherapies.
In March this year, Pilatus Biosciences dosed the first patient in its Phase I clinical trial of PLT012, a first-in-class anti-CD36 monoclonal antibody, at Next Oncology in Houston, Texas, US.
