Recruiting
Phase 2

Visugromab, Nivolumab & Lenvatinib

Sponsor:

CatalYm GmbH

Code:

NCT07219459

Conditions

Unresectable or Metastatic Hepatocellular Carcinoma

Child-Pugh A Hepatocellular Carcinoma

Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Visugromab RDE (recommended dose for expansion)

Nivolumab

Lenvatinib

Placebo Saline Infusion

Study Details

Brief summary:

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.

Conditions

Unresectable or Metastatic Hepatocellular Carcinoma

Child-Pugh A Hepatocellular Carcinoma

Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound

Study ID

NCT07219459

Start date

Mar 19, 2026

Status verified date

Jul, 2026

Completion date

Sep, 2031

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Visugromab (IV) + Nivolumab intravenous (IV) + Lenvatinib (PO)

active comparator: Arm B

Lenvatinib (PO) + saline (double-placebo) intravenous (IV)

Interventions

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

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

Lenvatinib

Participants receive Lenvatinib per os (PO) once daily according to body weight (> 60kg: 12mg; < 60kg: 8mg)

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

Primary outcome measure

  • Progression-free survival (PFS) [ Time Frame: up to 36 months ]

Central Contacts and Locations

Central contacts

Tomáš Janík, MD

+49892000664regulatory-005@catalym.com

Locations

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Anthony El-Khoueiry, Dr

+1 (323) 865 3000elkhouei@med.usc.edu

Charlean Ketchens

+1 (323) 865 3000ketchens_c@med.usc.edu

Peidmont Healthcare, Inc

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Sope Olugbile, MD

404 (425) 1777sope.olugbile@piedmont.org

Karma MCcants

404 (605) 2366karma.mccants@piedmont.org

OSF St. Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Robert McWilliams, Dr.

Robert.R.McWilliams@osfhealthcare.org

More Information

Sponsor

CatalYm GmbH

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • CTL-002
  • Visugromab
  • GDF-15

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CatalYm GmbH on 2026-07-21.