CatalYm has dosed the first subject in the Phase II GDFather-NEO clinical trial of visugromab (CTL-002) along with nivolumab to treat patients with muscle-invasive bladder cancer (MIBC).
The stratified, single-blinded, multicentre study will assess the safety and initial clinical efficacy signs of the combination treatment against nivolumab plus placebo.
It will enrol MIBC patients who are ready to undergo radical cystectomy and cannot receive or refuse to receive chemotherapy comprising cisplatin.
The trial will enrol 30 subjects at four study centres in Milan, Italy.
It will also offer data on relevant response-predictive biomarkers for the stratification of patients.
A monoclonal antibody, visugromab works by neutralising the tumour-derived growth differentiation factor-15 (GDF-15).
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Nivolumab is a neoadjuvant immunotherapy and an inhibitor of programmed cell death protein 1 (PD-1).
CatalYm CEO Dr Phil L’Huillier said: “This study provides us with the first opportunity to evaluate visugromab in an earlier clinical setting and allows us to gain a deeper understanding of its immunosupportive activity.
“It will also offer us expanded reference data on response-predictive biomarkers and provide further insights into visugromab’s extensive therapeutic potential for patients with hard-to-treat cancers that have built immune-resistance mechanisms.”
In June this year, the company reported positive data from the GDFather-2 trial of visugromab plus nivolumab in patients with advanced-stage solid tumours that relapsed or did not respond to previous treatment with anti-PD1/-L1 therapy.