Back to resultsA Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RZ-001 Dose 1
RZ-001 Dose 2
RZ-001 Dose 3
RZ-001 Dose 4
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with Dose limiting toxicities (DLT) in Part 1 as graded by NCI-CTCAE
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
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
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
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
Number of participants with adverse events (AEs) in part 1 and 2 as graded by NCI-CTCAE
Secondary Outcome Measures
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05595473
Brief Title
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Hepatocellular Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2022 (Actual)
Primary Completion Date
March 2029 (Anticipated)
Study Completion Date
May 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rznomics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Title
Cohort 2
Arm Type
Experimental
Arm Title
Cohort 3
Arm Type
Experimental
Arm Title
Cohort 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RZ-001 Dose 1
Intervention Description
RZ-001 Dose 1 and VGCV
Intervention Type
Drug
Intervention Name(s)
RZ-001 Dose 2
Intervention Description
RZ-001 Dose 2 and VGCV
Intervention Type
Drug
Intervention Name(s)
RZ-001 Dose 3
Intervention Description
RZ-001 Dose 3 and VGCV
Intervention Type
Drug
Intervention Name(s)
RZ-001 Dose 4
Intervention Description
RZ-001 Dose 4 and VGCV
Primary Outcome Measure Information:
Title
Number of participants with Dose limiting toxicities (DLT) in Part 1 as graded by NCI-CTCAE
Time Frame
Day 1 to Day 28
Title
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
Title
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
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rznomics Inc.
Phone
+82317068730
Email
rznomics@rznomics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hyunjin Yoon
Phone
+82-31-701-8735
Email
hjyoon@rznomics.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Han Paik
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Hepatocellular Carcinoma
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