Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure

Study acronym: GDFATHERHCC01
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Trial sites expanded: 14 → 23 locations
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 10 entries
  2. Study sites: 12 to 14v4
  3. Trial sites expanded: 2 → 12 locationsv3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Feb 2026 to Mar 19, 2026
    • Interventions: Nivolumab (Biological), Placebo Saline Infusion (Other), Tyrosine kinase inhibitor (TKI) (Drug), Visugromab RDE (recommended dose for… to Lenvatinib (Drug), Nivolumab (Biological), Placebo Saline Infusion (Other), Visugromab RDE (recommended dose for expansion) (Biological)
    • Secondary endpoints revised (10)
    • Study title shortened, about 5 words
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
CatalYm GmbH
6 trials monitored
See 1 trial at risk
Liver Cancer
1,602 trials monitored
See 70 trials at risk
This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and Lenvatinib compared to double placebo and Lenvatinib 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.
Trial Details
NCT Number NCT07219459
Lead Sponsor CatalYm GmbH
Conditions
(from sponsor)		 Unresectable or Metastatic Hepatocellular Carcinoma, Child-Pugh A Hepatocellular Carcinoma, Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound
Related terms Carcinoma, Hepatocellular
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov