A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Hepatocellular Carcinoma

Rznomics, Inc.

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: RZ-001 Dose 4; Drug: RZ-001 Dose 3; Drug: RZ-001 Dose 1; Drug: RZ-001 Dose 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05595473

RZ-001

Details and patient eligibility

About

This is first in human study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of RZ-001 when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.

Full description

The study will be conducted in 2 parts.

Part 1 is a dose escalation study which aims to explore the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) after the single escalating dose of the intratumoral (IT) injection given through 4 different cohorts.

Part 2 will consist of dose expansion, exploring clinical activity for the optimal fixed dose based on the results of Part 1.

Enrollment: 42 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 to B7
• 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: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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42 participants in 4 patient groups

Cohort 1

Experimental group

Treatment:

Drug: RZ-001 Dose 1

Cohort 2

Experimental group

Treatment:

Drug: RZ-001 Dose 2

Cohort 3

Experimental group

Treatment:

Drug: RZ-001 Dose 3

Cohort 4

Experimental group

Treatment:

Drug: RZ-001 Dose 4