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)

Официальное название

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)

Обзор

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)

Вмешательства

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

Первичные конечные точки

• Number of participants with adverse events (AEs) [Срок оценки: Up to approximately 25 weeks]
• Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5)) [Срок оценки: Up to approximately 25 weeks]
• Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [Срок оценки: Up to day 21]
• Number of participants with AEs leading to discontinuation [Срок оценки: Up to approximately 25 weeks]
• Number of participants with AEs leading to death [Срок оценки: 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 [Срок оценки: Up to week 48]

Вторичные конечные точки (12)

• Number of participants with AEs [Срок оценки: Up to approximately 25 weeks]
• Number of participants with SAEs (as per CTCAE v5) [Срок оценки: Up to approximately 25 weeks]
• Number of participants with treatment-related adverse events (TRAEs) [Срок оценки: Up to approximately 25 weeks]
• Number of participants with AEs leading to discontinuation [Срок оценки: Up to approximately 25 weeks]
• Number of participants with AEs leading to death [Срок оценки: Up to approximately 25 weeks]
• End of infusion concentration of Pumitamig [Срок оценки: Up to day 21]
• End of trough concentration of Pumitamig [Срок оценки: Up to day 21]
• Trough concentration of Ipilimumab [Срок оценки: Up to day 21]
• Incidence of anti-drug antibodies against Pumitamig [Срок оценки: Up to 5 years]
• Incidence of anti-drug antibodies against Ipilimumab [Срок оценки: Up to 5 years]
• Progression-free survival (PFS) by RECIST v1.1 per investigator assessment [Срок оценки: Up to 4 years]
• Duration of response (DOR) (confirmed by PR or CR) by RECIST v1.1 per investigator assessment [Срок оценки: Up to 4 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 13 центров

• Local Institution - 0114 — Пекин
• Local Institution - 0125 — Чунцин
• Local Institution - 0116 — Фучжоу
• Local Institution - 0075 — Гуанчжоу
• Local Institution - 0130 — Харбин
• Local Institution - 0128 — Nanyang
• Local Institution - 0119 — Нанкин
• Local Institution - 0123 — Nanchang
• … и ещё 5 центров

США · 11 центров

• 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
• … и ещё 3 центра

Франция · 5 центров

• 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

Австралия · 4 центра

• Royal Prince Alfred Hospital — Camperdown
• Local Institution - 0033 — Westmead
• Sunshine Coast University Hospital — Birtinya
• The Royal Melbourne Hospital — Parkville

Германия · 4 центра

• Local Institution - 0031 — Cologne
• Universitatsklinikum Schleswig-Holstein — Lübeck
• Universitaetsklinikum Frankfurt — Frankfurt
• Local Institution - 0026 — Mainz

Италия · 4 центра

• IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola
• Local Institution - 0109 — Pisa
• Local Institution - 0089 — Milan
• Local Institution - 0016 — Pisa

Испания · 4 центра

• Local Institution - 0014 — Pamplona
• Local Institution - 0015 — Barcelona
• Hospital General Universitario Gregorio Marañon — Madrid
• Local Institution - 0095 — Madrid

Тайвань · 4 центра

• Local Institution - 0032 — Taichung
• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei
• Taipei Veterans General Hospital — Taipei

Польша · 3 центра

• Local Institution - 0021 — Wroclaw
• Local Institution - 0105 — Warsaw
• Local Institution - 0020 — Gdansk

South Korea · 3 центра

• Local Institution - 0027 — Seongnam-si
• Local Institution - 0013 — Seoul
• Local Institution - 0011 — Seoul

Великобритания · 3 центра

• Hammersmith Hospital — London
• Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson — Glasgow
• Local Institution - 0053 — Metropolitan Borough of Wirral

Чили · 2 центра

• Bradfordhill — Santiago
• Pontifica Universidad Catolica De Chile — Santiago Region Metropolitana

Япония · 2 центра

• Local Institution - 0017 — Osakasayama-shi
• Local Institution - 0008 — Kashiwa

Сингапур · 2 центра

• Local Institution - 0009 — Singapore
• Local Institution - 0012 — Singapore

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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