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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
| |
| Cohort 3 | Experimental |
| |
| Cohort 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RZ-001 Dose 1 | Drug | RZ-001 Dose 1 and VGCV |
| |
| RZ-001 Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul | 06351 | South Korea | ||
| Kyungpook National University Hospital |
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| 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 |
|
| 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 |
| Deagu |
| 41944 |
| South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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