CatalYm Doses First Patient in Phase 2b Trial Evaluating Visugromab in Combination with Chemoimmunotherapy as Second-Line Treatment in Unresectable/Metastatic Hepatocellular Carcinoma
- Study targets patients with unresectable or metastatic hepatocellular carcinoma who have progressed following first-line anti-PD-(L)1-based therapy
- Initiation of the third Phase 2b study of visugromab, expanding development into hepatocellular carcinoma following first and second-line NSCLC programs
Excerpt from the Press Release:
MUNICH & SAN FRANCISCO–(BUSINESS WIRE)–CatalYm today announced that the first patient has been dosed in the GDFATHER-HCC-01 trial (NCT07219459). The trial evaluates the company’s lead anti-GDF-15 antibody visugromab in combination with chemoimmunotherapy as a second-line (2L) treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The Phase 2b trial targets patients who have progressed following 1L treatment with an anti-PD-(L)1-based therapy.
The trial will assess a treatment strategy combining visugromab with the PD-1 inhibitor nivolumab and the multi-target tyrosine kinase inhibitor (TKI) lenvatinib. The study consists of an open-label safety run-in to confirm the recommended dose for expansion, followed by a randomized, double-blind phase evaluating visugromab plus nivolumab plus lenvatinib versus double placebo plus lenvatinib.
Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), an immunosuppressive cytokine exploited by tumor cells to promote immune evasion and resistance to anti-PD-(L)1 therapies. By neutralizing GDF-15, visugromab aims to restore anti-tumor immune responses to improve outcomes in a setting where 5-year overall survival remains as low as 18%.1 In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab demonstrated encouraging anti-tumor activity when combined with an anti-PD-1 antibody in advanced-stage, anti-PD-(L)1 relapsed/refractory HCC patients, demonstrating deep and durable responses, with a median duration of response of 21.4 months and a favorable safety profile.
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