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Recruiting NCT07291076

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

Phase I / Phase II Interventional Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pumitamig, Ipilimumab.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Chile, China, France +9
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1/2 Study of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)

Overview

The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)

Interventions

  • Drug Pumitamig
    Specified dose on specified days
  • Drug Ipilimumab
    Specified dose on specified days

Primary outcome measures

  • Number of participants with adverse events (AEs) [Time frame: Up to approximately 25 weeks]
  • Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5)) [Time frame: Up to approximately 25 weeks]
  • Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [Time frame: Up to day 21]
  • Number of participants with AEs leading to discontinuation [Time frame: Up to approximately 25 weeks]
  • Number of participants with AEs leading to death [Time frame: Up to approximately 25 weeks]
  • Objective response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment [Time frame: Up to week 48]
Secondary outcome measures (12)
  • Number of participants with AEs [Time frame: Up to approximately 25 weeks]
  • Number of participants with SAEs (as per CTCAE v5) [Time frame: Up to approximately 25 weeks]
  • Number of participants with treatment-related adverse events (TRAEs) [Time frame: Up to approximately 25 weeks]
  • Number of participants with AEs leading to discontinuation [Time frame: Up to approximately 25 weeks]
  • Number of participants with AEs leading to death [Time frame: Up to approximately 25 weeks]
  • End of infusion concentration of Pumitamig [Time frame: Up to day 21]
  • End of trough concentration of Pumitamig [Time frame: Up to day 21]
  • Trough concentration of Ipilimumab [Time frame: Up to day 21]
  • Incidence of anti-drug antibodies against Pumitamig [Time frame: Up to 5 years]
  • Incidence of anti-drug antibodies against Ipilimumab [Time frame: Up to 5 years]
  • Progression-free survival (PFS) by RECIST v1.1 per investigator assessment [Time frame: Up to 4 years]
  • Duration of response (DOR) (confirmed by PR or CR) by RECIST v1.1 per investigator assessment [Time frame: Up to 4 years]

Eligibility criteria

Inclusion criteria

  • Participants must have a histologically confirmed diagnosis of locally advanced or unresectable Hepatocellular Carcinoma (HCC).
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participants must have no prior systemic therapy for advanced/ unresectable HCC.
  • Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion criteria

  • Participants must not have significant bleeding or coagulation disorders or other obvious bleeding risk evidence.
  • Participants must not have an organ transplant or autoimmune disease.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 13 centers
  • Local Institution - 0114 — Beijing
  • Local Institution - 0125 — Chongqing
  • Local Institution - 0116 — Fuzhou
  • Local Institution - 0075 — Guangzhou
  • Local Institution - 0130 — Harbin
  • Local Institution - 0128 — Nanyang
  • Local Institution - 0119 — Nanjing
  • Local Institution - 0123 — Nanchang
  • … and 5 more centers
United States · 11 centers
  • Local Institution - 0137 — Duarte
  • Local Institution - 0070 — Los Angeles
  • Local Institution - 0107 — Chicago
  • Local Institution - 0134 — Detroit
  • John Theurer Cancer Center at Hackensack University Medical Center — Hackensack
  • Local Institution - 0100 — Mineola
  • Providence Portland Medical Center — Portland
  • Providence St. Vincent Medical Center — Portland
  • … and 3 more centers
France · 5 centers
  • CHU Bordeaux Haut-Leveque — Pessac
  • Centre Hospitalier Universitaire de Grenoble — La Tronche
  • Local Institution - 0001 — Montpellier
  • Local Institution - 0018 — Saint Priest En Jarez
  • Local Institution - 0003 — Bobigny
Australia · 4 centers
  • Royal Prince Alfred Hospital — Camperdown
  • Local Institution - 0033 — Westmead
  • Sunshine Coast University Hospital — Birtinya
  • The Royal Melbourne Hospital — Parkville
Germany · 4 centers
  • Local Institution - 0031 — Cologne
  • Universitatsklinikum Schleswig-Holstein — Lübeck
  • Universitaetsklinikum Frankfurt — Frankfurt
  • Local Institution - 0026 — Mainz
Italy · 4 centers
  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola
  • Local Institution - 0109 — Pisa
  • Local Institution - 0089 — Milan
  • Local Institution - 0016 — Pisa
Spain · 4 centers
  • Local Institution - 0014 — Pamplona
  • Local Institution - 0015 — Barcelona
  • Hospital General Universitario Gregorio Marañon — Madrid
  • Local Institution - 0095 — Madrid
Taiwan · 4 centers
  • Local Institution - 0032 — Taichung
  • National Cheng Kung University Hospital — Tainan
  • National Taiwan University Hospital — Taipei
  • Taipei Veterans General Hospital — Taipei
Poland · 3 centers
  • Local Institution - 0021 — Wroclaw
  • Local Institution - 0105 — Warsaw
  • Local Institution - 0020 — Gdansk
South Korea · 3 centers
  • Local Institution - 0027 — Seongnam-si
  • Local Institution - 0013 — Seoul
  • Local Institution - 0011 — Seoul
United Kingdom · 3 centers
  • Hammersmith Hospital — London
  • Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson — Glasgow
  • Local Institution - 0053 — Metropolitan Borough of Wirral
Chile · 2 centers
  • Bradfordhill — Santiago
  • Pontifica Universidad Catolica De Chile — Santiago Region Metropolitana
Japan · 2 centers
  • Local Institution - 0017 — Osakasayama-shi
  • Local Institution - 0008 — Kashiwa
Singapore · 2 centers
  • Local Institution - 0009 — Singapore
  • Local Institution - 0012 — Singapore

Identifiers

NCT: NCT07291076 · CA266-0006 · 2025-523602-33 · U1111-1327-4912

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗