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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-29

Study Completion Date

2029-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

RZ-001 Dose 1 and VGCV

Intervention Type DRUG

RZ-001 Dose 2

RZ-001 Dose 2 and VGCV

Intervention Type DRUG

RZ-001 Dose 3

RZ-001 Dose 3 and VGCV

Intervention Type DRUG

RZ-001 Dose 4

RZ-001 Dose 4 and VGCV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No