NCT07219459View on ClinicalTrials.gov

Visugromab, Nivolumab and a Tyrosine Kinase Inhibitor (TKI) Compared to Double Placebo and a TKI in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

February 28, 2026

Primary Completion Date

September 30, 2029

Study Completion Date

September 30, 2031

Conditions
Unresectable or Metastatic Hepatocellular CarcinomaFailure of First-Line Treatment That Included an Anti PD-(L)1 CompoundChild-Pugh A Hepatocellular Carcinoma
Interventions
BIOLOGICAL

Visugromab RDE (recommended dose for expansion)

Participants receive visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments

BIOLOGICAL

Nivolumab

Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments after visugromab infusion

DRUG

Tyrosine kinase inhibitor (TKI)

Participants receive the TKI (PO)

OTHER

Placebo Saline Infusion

Saline (0.9%NaCl) intravenous (2x IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) for up to 35 treatments

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

CatalYm GmbH

INDUSTRY