NCT05595473

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Timeline
33mo left

Started Jul 2022

Longer than P75 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jul 2022May 2029

Study Start

First participant enrolled

July 29, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

6.6 years

First QC Date

September 7, 2022

Last Update Submit

October 31, 2024

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (6)

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

    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

    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

    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

    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

    Day 1 to Day 15

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

    Day 1 to Day 28

Secondary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

Cohort 1

EXPERIMENTAL
Drug: RZ-001 Dose 1

Cohort 2

EXPERIMENTAL
Drug: RZ-001 Dose 2

Cohort 3

EXPERIMENTAL
Drug: RZ-001 Dose 3

Cohort 4

EXPERIMENTAL
Drug: RZ-001 Dose 4

Interventions

RZ-001 Dose 1DRUG

RZ-001 Dose 1 and VGCV

Cohort 1
RZ-001 Dose 2DRUG

RZ-001 Dose 2 and VGCV

Cohort 2
RZ-001 Dose 3DRUG

RZ-001 Dose 3 and VGCV

Cohort 3
RZ-001 Dose 4DRUG

RZ-001 Dose 4 and VGCV

Cohort 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Moderate or severe ascites
  • History of hepatic encephalopathy
  • Carcinomas other than HCC
  • Current or history of HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

Kyungpook National University Hospital

Deagu, 41944, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2022

First Posted

October 27, 2022

Study Start

July 29, 2022

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

November 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(5)