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NCT Number: NCT05595473

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Samsung Medical Center, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RZ-001 Dose 1

Drug

RZ-001 Dose 1 and VGCV

RZ-001 Dose 2

Drug

RZ-001 Dose 2 and VGCV

RZ-001 Dose 3

Drug

RZ-001 Dose 3 and VGCV

RZ-001 Dose 4

Drug

RZ-001 Dose 4 and VGCV

Primary outcomes

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

    Time frame: Day 1 to Day 28

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  1. 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

  2. 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

  3. 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

    Time frame: Day 1 to Day 15

  4. 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

    Time frame: Day 1 to Day 15

Sponsors and collaborators

Lead sponsor

Rznomics, Inc.

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Oct 27, 2022
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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