CatalYm initiates Phase 2/3 VINCIT trial of visugromab targeting Growth Differentiation Factor-15 in cancer cachexia patients.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
CatalYm has dosed the first patient in its Phase 2/3 VINCIT trial (NCT07112196), evaluating visugromab in patients with cancer-associated cachexia, a severe metabolic condition characterized by involuntary weight loss, muscle wasting, and reduced treatment tolerance.
The randomized, double-blind, placebo-controlled study plans to enroll approximately 518 patients with advanced cancers, including non-small cell lung cancer, colorectal cancer, and other solid tumors. The adaptive trial design includes an initial phase assessing three dose levels of visugromab versus placebo over 12 weeks, followed by a second phase evaluating a selected dose in a larger cohort for up to 52 weeks.
Primary endpoints include changes in body weight and appetite, with secondary measures assessing muscle mass, physical function, tumor response, overall survival, quality of life, and safety.
Cancer cachexia remains a significant unmet medical need, affecting a large proportion of patients with advanced disease and contributing substantially to mortality, with no approved pharmacological treatments currently available. The study targets Growth Differentiation Factor-15, a tumor-derived cytokine implicated in immune suppression and metabolic dysfunction, with elevated levels linked to appetite loss, weight decline, and poor clinical outcomes.
Visugromab is a humanized monoclonal antibody designed to neutralize GDF-15, with the aim of restoring immune activity and improving metabolic balance. It also targets signaling through the GFRAL receptor in the brainstem, a key pathway driving appetite suppression and weight loss in cancer patients.
Early findings from the Phase 1/2a GDFATHER study showed that visugromab, in combination with the PD-1 inhibitor nivolumab, demonstrated anti-tumor activity and a favorable safety profile in patients with relapsed or refractory cancers, along with evidence of weight gain in those with baseline weight loss.
Sujata Rao, Chief Medical Officer at CatalYm, noted that cachexia remains a serious and under-treated complication in oncology, adding that prior clinical data showing weight gain and growing evidence around GDF-15 support further development of visugromab. Scott
Clarke, Chief Executive Officer at CatalYm, emphasized that GDF-15 plays a central role in both immune resistance and metabolic decline, and that targeting this pathway may offer a new therapeutic approach for patients affected by cachexia.
The ongoing VINCIT trial is expected to further define visugromab’s potential as a treatment targeting both tumor progression and cancer-associated cachexia.
Reference
Study Details | NCT07112196 | Visugromab in Cachexia International Trial | ClinicalTrials.gov
About the Writer
Mahathi Palivela is pursuing PharmD and has a strong interest in Clinical Pharmacy and Patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in Medical Writing and Pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication .