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

Sponsor
Rznomics, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT05595473
Collaborator
(none)
42
Enrollment
1
Location
4
Arms
81.1
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: RZ-001 Dose 1
  • Drug: RZ-001 Dose 2
  • Drug: RZ-001 Dose 3
  • Drug: RZ-001 Dose 4
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 29, 2022
Anticipated Primary Completion Date :
Mar 1, 2029
Anticipated Study Completion Date :
May 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Drug: RZ-001 Dose 1
RZ-001 Dose 1 and VGCV
Experimental: Cohort 2

Drug: RZ-001 Dose 2
RZ-001 Dose 2 and VGCV
Experimental: Cohort 3

Drug: RZ-001 Dose 3
RZ-001 Dose 3 and VGCV
Experimental: Cohort 4

Drug: RZ-001 Dose 4
RZ-001 Dose 4 and VGCV

Outcome Measures

Primary Outcome Measures

  1. Number of participants with Dose limiting toxicities (DLT) in Part 1 as graded by NCI-CTCAE [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 [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 [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 [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 [Day 1 to Day 15]

  6. Number of participants with adverse events (AEs) in part 1 and 2 as graded by NCI-CTCAE [Day 1 to Day 28]

Secondary Outcome Measures

  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 [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 [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 [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 [Day 1 to Day 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 06351

Sponsors and Collaborators

  • Rznomics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rznomics, Inc.
ClinicalTrials.gov Identifier:
NCT05595473
Other Study ID Numbers:
  • RZ-001
First Posted:
Oct 27, 2022
Last Update Posted:
Oct 27, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Oct 27, 2022