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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase 1/2a, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability and Efficacy of RZ-001 in Combination With Valganciclovir in Subjects With Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595473
• Other study ID #: RZ-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 29, 2022
• Est. completion date: May 2029

Study information

• Verified date: October 2022
• Source: Rznomics, Inc.
• Contact: Rznomics Inc.
• Phone: +82317068730
• Email: rznomics[@]rznomics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: May 2029
• Est. primary completion date: March 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• RZ-001 Dose 1
RZ-001 Dose 1 and VGCV
• RZ-001 Dose 2
RZ-001 Dose 2 and VGCV
• RZ-001 Dose 3
RZ-001 Dose 3 and VGCV
• RZ-001 Dose 4
RZ-001 Dose 4 and VGCV

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Rznomics, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Dose limiting toxicities (DLT) in Part 1 as graded by NCI-CTCAE		Day 1 to Day 28
Primary	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		Day 1 to Day 15
Primary	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		Day 1 to Day 15
Primary	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		Day 1 to Day 15
Primary	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		Day 1 to Day 15
Primary	Number of participants with adverse events (AEs) in part 1 and 2 as graded by NCI-CTCAE		Day 1 to Day 28
Secondary	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		Day 1 to Day 15
Secondary	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		Day 1 to Day 15
Secondary	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		Day 1 to Day 15
Secondary	To determine safety and efficacy of RZ-001 by changes in overall survival (OS) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST		Day 1 to Day 15