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This study is to evaluate the safety, tolerability, efficacy and immunogenicity of RZ-001 in combination with Valganciclovir (VGCV) and Atezolizumab/Bevacizumab when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.
15 subjects will be enrolled in each of the 3 cohorts. Once enrollment of the first 3 of 15 subjects is completed, Safety and Efficacy Review Committee (SERC) meeting involving the study Investigators and the Sponsor's clinical study team will be held after Day 43 (Week 6) visit of the third subject enrolled. After the data from enrolled subjects is reviewed in the meeting, dose escalation to the next dose will be determined, based on the number of subjects experiencing dose-limiting toxicity (DLT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | o Interventions: Drug: RZ-001 Dose 1 |
|
| Cohort 2 | Experimental | o Interventions: Drug: RZ-001 Dose 2 |
|
| Cohort 3 | Experimental | o Interventions: Drug: RZ-001 Dose 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RZ-001 Dose 1 | Drug | RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) as graded by NCI CTCAE | Screening visit, up to 2 years | |
| Assessment of tumor response of target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST | Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years | |
| Overall response rate based on RECIST v1.1 and HCC mRECIST | Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of tumor response of non-target lesions, besides the target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST | Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years | |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rznomics, Inc. | Contact | +82-31-706-8730 | rznomics@rznomics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Recruiting | Busan | South Korea | |||
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| RZ-001 Dose 2 |
| Drug |
RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab |
|
| RZ-001 Dose 3 | Drug | RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab |
|
| Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years |
| Overall survival (OS) | Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years |
| Duration of response (DOR) | Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years |
| Kyungpook National University Hospital |
| Recruiting |
| Daegu |
| South Korea |
| Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting | Seoul | South Korea |
| Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
| Kangbuk Samsung Medical Center | Recruiting | Seoul | South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | South Korea |
| Samsung Medical Center | Recruiting | Seoul | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| Severance Hospital | Recruiting | Seoul | 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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