CatalYm has dosed the first patient in its global GDFATHER-HCC-01 study, a phase 2b trial evaluating visugromab in combination with chemoimmunotherapy for people with unresectable or metastatic hepatocellular carcinoma who have progressed after first-line anti-PD-(L)1 therapy.
The study will test visugromab alongside nivolumab and the tyrosine kinase inhibitor lenvatinib. It begins with an open-label safety run-in to confirm the recommended dose for expansion, followed by a randomized, double-blind phase comparing the triple combination with double placebo plus lenvatinib.
Visugromab is designed to neutralise GDF-15, an immunosuppressive cytokine used by tumour cells to evade immune attack. CatalYm notes that restoring immune sensitivity could be particularly valuable in a setting where long-term survival remains poor. Earlier data from the exploratory phase 1/2a GDFATHER trial showed what the company described as encouraging anti-tumour activity when visugromab was combined with an anti-PD-1 antibody.
Sujata Rao, MD, Chief Medical Officer at CatalYm, said: “HCC is the third leading cause of cancer-related deaths globally and continues to present immense clinical challenges, especially in patients who progress on immunotherapy.”
She added: “This new trial is designed to combine the immune-restoring properties of visugromab with a checkpoint inhibitor and the standard of care tyrosine kinase inhibitor. With this approach we aim to improve clinical outcomes for HCC patients with limited treatment options.”
Scott Clarke, Chief Executive Officer at CatalYm, explained: “Expanding into HCC represents a pivotal step in our strategy to bring visugromab to additional high-need tumor types.” He said: “By combining our antibody with proven standards of care, we aim to shift the treatment paradigm and ultimately improve survival and quality of life for patients who have few options today.”
The trial will enrol around 104 participants across 40 sites in North America, Europe and Asia-Pacific. Its primary endpoint is progression-free survival, with secondary measures including overall survival, objective response rate and assessments of visugromab’s potential to mitigate cancer cachexia.
