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

Phase 2Active Not RecruitingNCT05595473

Rznomics, Inc.42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

RZ-001 Dose 1DRUG

RZ-001 Dose 1 and VGCV

RZ-001 Dose 2DRUG

RZ-001 Dose 2 and VGCV

RZ-001 Dose 3DRUG

RZ-001 Dose 3 and VGCV

RZ-001 Dose 4

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Samsung Medical Center

Seoul, Seoul, South Korea

Kyungpook National University Hospital

Deagu, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Number of participants with Dose limiting toxicities (DLT) in Part 1 as graded by NCI-CTCAE

Time frame: Day 1 to Day 28

To determine safety and efficacy of RZ-001 by changes in overall response rate (ORR) for participants in part 2 as graded by RECIST v1.1 and mRECIST

Time frame: Day 1 to Day 15

To determine safety and efficacy of RZ-001 by changes in duration of response (DOR) in part 2 as graded by RECIST v1.1 and mRECIST

Time frame: Day 1 to Day 15

To determine safety and efficacy of RZ-001 by changes in Progression free survial (PFS) of participants in part 2 as graded by RECIST v1.1 and mRECIST

Time frame: Day 1 to Day 15

To determine safety and efficacy of RZ-001 by changes in overall survival (OS) of participants in part 2 as graded by RECIST v1.1 and mRECIST

Time frame: Day 1 to Day 15

Number of participants with adverse events (AEs) in part 1 and 2 as graded by NCI-CTCAE

Time frame: Day 1 to Day 28

Secondary Outcomes

To determine safety and efficacy of RZ-001 by changes in overall response rate (ORR) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST

Time frame: Day 1 to Day 15

To determine safety and efficacy of RZ-001 by changes in duration of response (DOR) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST

Time frame: Day 1 to Day 15

To determine safety and efficacy of RZ-001 by changes in Progression free survial (PFS) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.