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NCT07219459

PHASE2

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

Sponsor: CatalYm GmbH

View on ClinicalTrials.gov

Summary

This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and a TKI compared to double placebo and a TKI in participants with unresectable or metastatic HCC and compensated liver function (Child-Pugh A) after failure of 1L treatment that included an anti-PD-(L)1 compound. The trial consists of 2 Parts: a non-randomized Safety-run-in part (Part 1) and the subsequent randomized part (Part 2) with 2 treatment arms (A and B). Randomization of participants into Treatment Arm A and B will continue until 40 efficacy-evaluable participants are enrolled into each Treatment Arm.

Official title: A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in Combination With Nivolumab and a Tyrosine Kinase Inhibitor Compared to Double Placebo and a Tyrosine Kinase Inhibitor in Participants With Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) After Failure of First-Line Treatment That Included an Anti PD-(L)1 Compound (GDFATHER HCC-01)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-02

Completion Date

2031-09

Last Updated

2025-10-21

Healthy Volunteers

Conditions

Unresectable or Metastatic Hepatocellular Carcinoma Failure of First-Line Treatment That Included an Anti PD-(L)1 Compound Child-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

Main Inclusion Criteria: * Histologically confirmed diagnosis of unresectable or metastatic HCC, not amenable to a curative treatment approach. * Measurable disease as per RECIST v1.1 as determined by the Investigator based upon local radiologist assessment. * Must have failed one line of prior systemic treatment for unresectable or metastatic HCC containing an approved anti PD (L)-1 checkpoint inhibitor (CPI) with a minimum treatment duration of 12 weeks exposure for the CPI with no documented progression in this period. * Age ≥ 18 years on the day of signing the informed consent. * Life expectancy of at least 3 months as assessed by the Investigator. * ECOG performance status ≤1. * Child-Pugh score of A6 or better. Main Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma. * More than 1 line of prior systemic treatment for unresectable or metastatic HCC. * Received or completed any palliative radiotherapy for symptoms within 28 days of the first dose of IMP. * Expected to require any other form of antineoplastic therapy during the trial. * Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction. * Known history of other prior malignancy unless participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. * Known or detected clinically active central nervous system (CNS) involvement by HCC or other tumors. * Have one of the following cardiovascular risk factors: myocardial infarction, peri/myocarditis, or history of ischemic stroke in the past 3 months before planned treatment start, uncontrolled heart failure, uncontrolled ventricular arrhythmia, QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex. * An active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start. * Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes. * Chronic systemic corticosteroid treatment for other reasons. * Prior liver or other organ transplantation.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States