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

Rznomics, Inc.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: RZ-001 Dose 3; Drug: RZ-001 Dose 1; Drug: RZ-001 Dose 2

Study type: Interventional

Funder types: Other

Identifiers

NCT06695026

RZ-001-102

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Cohort 1

Experimental group

Description:

o Interventions: Drug: RZ-001 Dose 1

Treatment:

Drug: RZ-001 Dose 1

Cohort 2

Experimental group

Description:

o Interventions: Drug: RZ-001 Dose 2

Treatment:

Drug: RZ-001 Dose 2

Cohort 3

Experimental group

Description:

o Interventions: Drug: RZ-001 Dose 3

Treatment:

Drug: RZ-001 Dose 3