Menu
Recruiting 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

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: RZ-001 Dose 1, RZ-001 Dose 2, RZ-001 Dose 3.
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
South Korea
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

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

Overview

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.

Detailed description

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).

Interventions

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

Primary outcome measures

  • Number of participants with adverse events (AEs) as graded by NCI CTCAE [Time frame: 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 [Time frame: 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 [Time frame: 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]
Secondary outcome measures (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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 9 centers
  • 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
  • … and 1 more center

Identifiers

NCT: NCT06695026 · RZ-001-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗