CatalYm has dosed the first patient in its Phase IIb GDFATHER-HCC-01 clinical trial, assessing visugromab, along with chemoimmunotherapy as a second-line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC).
The blinded, randomised, global study focuses on patients who have shown progression after first-line therapy with an anti-programmed death (PD)-(L)1-based therapy.
It will evaluate visugromab in conjunction with the PD-1 inhibitor nivolumab and the tyrosine kinase inhibitor lenvatinib.
The trial begins with an open-label safety run-in to establish the recommended dose for expansion, and continues with a randomised, double-blind phase comparing visugromab plus nivolumab and lenvatinib against a double placebo plus lenvatinib.
Visugromab neutralises growth differentiation factor-15 (GDF-15), an immunosuppressive cytokine that supports tumour immune evasion and contributes to resistance to anti-PD-(L)1 treatments.
By neutralising GDF-15, the monoclonal antibody intends to restore anti-tumour immune responses, improving outcomes.
CatalYm CEO Scott Clarke said: “Expanding into HCC represents a pivotal step in our strategy to bring visugromab to additional high-need tumour types. Visugromab’s dual potential to restore immune sensitivity and address cancer cachexia, which affects nearly one in four patients with HCC at diagnosis, underpins our approach in this study.
“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 104 participants across 40 sites in Europe, Asia-Pacific and North America.
Its primary endpoint is investigator-assessed progression-free survival (PFS) while secondary endpoints include overall survival, independently assessed PFS, and objective response rate.
The study will also evaluate visugromab’s impact on cancer cachexia using the Functional Assessment of the Anorexia and Cachexia Therapy questionnaire, addressing the prevalence and impact of muscle wasting and weight loss in HCC.
