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NCT06695026 | NOT YET RECRUITING | Hepatocellular Carcinoma (HCC)

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
Sponsor:

Rznomics, Inc.

Brief Summary:

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.

Condition or disease

Hepatocellular Carcinoma (HCC)

Intervention/treatment

RZ-001 Dose 1

RZ-001 Dose 2

RZ-001 Dose 3

Phase

PHASE1

PHASE2

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 45 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2027-08
Estimated Study Completion Date : 2027-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
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

Location Details

NCT06695026

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Korea, Republic of,

Kyungpook National University Hospital

Daegu, Korea, Republic of,

Not yet recruiting

Korea, Republic of,

Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Korea, Republic of,

Not yet recruiting

Korea, Republic of,

Samsung Medical Center

Seoul, Korea, Republic of,

Not yet recruiting

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of,

Not yet recruiting

Korea, Republic of,

Severance Hospital

Seoul, Korea, Republic of,