CatalYm has commenced dosing the first subject in its Phase II/III VINCIT trial, assessing the safety and efficacy of its lead anti-GDF-15 antibody, visugromab, in cancer-associated cachexia.
The double-blind, placebo-controlled, randomised trial aims to enrol approximately 518 participants with cachexia linked to advanced cancers, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and other solid tumours.
Cachexia is a metabolic disorder marked by involuntary weight loss, muscle wasting, and impaired treatment tolerance.
In certain cancer subtypes, it can affect up to 70% of patients and is responsible for 20%-40% of cancer-related deaths.
Elevated GDF-15 levels have been identified as central to the pathogenesis of cachexia. Despite high unmet medical needs, there are currently no approved pharmacological therapies for this condition.
CatalYm chief medical officer Sujata Rao said: “Cachexia remains one of the most debilitating and under-addressed complications in oncology.
“Following the promising weight gain data observed in our earlier trial and growing evidence of GDF-15’s role in metabolic wasting, this trial is a critical step in establishing visugromab as a novel therapeutic option for patients with advanced cancers.”
The adaptive trial is enrolling patients at clinical sites globally. In Part I, participants are randomised to receive one of three visugromab dose levels or a placebo every four weeks for 12 weeks.
Following interim analyses, a recommended dose will be selected for Part II, in which patients are randomised in a 2:1 ratio to visugromab or placebo for up to 52 weeks.
Primary endpoints are changes in body weight and appetite over 12 weeks. Secondary endpoints include physical activity and function, measures of muscle mass, overall survival, tumour response, patient-reported safety, and quality of life.
The study also incorporates exploratory pharmacodynamic and biomarker analyses.
Visugromab is a humanised monoclonal antibody targeting GDF-15, implicated in immune suppression and tumour-driven cachexia.
Earlier clinical data from the exploratory Phase I/IIa GDFATHER trial showed anti-tumour activity and safety in patients with hepatocellular carcinoma, relapsed or refractory NSCLC, and urothelial cancer, along with early evidence for visugromab’s role in addressing cancer cachexia.
Earlier this month, CatalYm 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).
