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Идёт набор NCT06695026

A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 in Combination With Valganciclovir (VGCV) and Atezolizumab/Bevacizumab in Subjects With Hepatocellular Carcinoma

Фаза I / Фаза II С лечением Hepatocellular Carcinoma (HCC)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: RZ-001 Dose 1, RZ-001 Dose 2, RZ-001 Dose 3.
Кому может быть актуально
Состояния в реестре: Hepatocellular Carcinoma (HCC). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1b/2a, Open-label, Multicenter, Randomized, Dose Escalation Study Evaluating the Safety, Tolerability and Efficacy of RZ-001 in Combination With Valganciclovir and Atezolizumab/Bevacizumab in Subjects With Hepatocellular Carcinoma

Обзор

This study is to evaluate the safety, tolerability, efficacy and immunogenicity of RZ-001 in combination with Valganciclovir (VGCV) and Atezolizumab/Bevacizumab when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.

Подробное описание

15 subjects will be enrolled in each of the 3 cohorts. Once enrollment of the first 3 of 15 subjects is completed, Safety and Efficacy Review Committee (SERC) meeting involving the study Investigators and the Sponsor's clinical study team will be held after Day 43 (Week 6) visit of the third subject enrolled. After the data from enrolled subjects is reviewed in the meeting, dose escalation to the next dose will be determined, based on the number of subjects experiencing dose-limiting toxicity (DLT).

Вмешательства

  • Препарат RZ-001 Dose 1
    RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab
  • Препарат RZ-001 Dose 2
    RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab
  • Препарат RZ-001 Dose 3
    RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab

Первичные конечные точки

  • Number of participants with adverse events (AEs) as graded by NCI CTCAE [Срок оценки: Screening visit, up to 2 years]
  • Assessment of tumor response of target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST [Срок оценки: Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years]
  • Overall response rate based on RECIST v1.1 and HCC mRECIST [Срок оценки: Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years]
Вторичные конечные точки (4)
  • Assessment of tumor response of non-target lesions, besides the target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST [Срок оценки: Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years]
  • Progression-free survival (PFS) [Срок оценки: Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years]
  • Overall survival (OS) [Срок оценки: Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years]
  • Duration of response (DOR) [Срок оценки: Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years]

Критерии участия

Критерии включения

  • Adult males and females
  • Hepatocellular carcinoma diagnosis (BCLC stage B or C)
  • hTERT positive expression confirmed during the screening period
  • ECOG score of 0 or 1
  • Child-Pugh score of A
  • Life expectancy >= 3 months

Критерии исключения

  • Moderate or severe ascites
  • History of hepatic encephalopathy
  • Carcinomas other than HCC
  • Current or history of HIV positive
  • Not suitable for inclusion judged by the investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 9 центров
  • Pusan National University Yangsan Hospital — Busan
  • Kyungpook National University Hospital — Daegu
  • Catholic University of Korea, Seoul St. Mary's Hospital — Seoul
  • Gangnam Severance Hospital — Seoul
  • Kangbuk Samsung Medical Center — Seoul
  • Korea University Guro Hospital — Seoul
  • Samsung Medical Center — Seoul
  • Seoul National University Hospital — Seoul
  • … и ещё 1 центр

Идентификаторы

NCT: NCT06695026 · RZ-001-102

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗