A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 in Combination with Valganciclovir (VGCV) and Atezolizumab/Bevacizumab in Subjects with Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma (HCC)
- Interventions
- Drug: RZ-001 Dose 1Drug: RZ-001 Dose 2Drug: RZ-001 Dose 3
- Registration Number
- NCT06695026
- Lead Sponsor
- Rznomics, Inc.
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- Life expectancy >= 3 months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 RZ-001 Dose 1 o Interventions: Drug: RZ-001 Dose 1 Cohort 2 RZ-001 Dose 2 o Interventions: Drug: RZ-001 Dose 2 Cohort 3 RZ-001 Dose 3 o Interventions: Drug: RZ-001 Dose 3
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 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) 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
Trial Locations
- Locations (5)
Kyungpook National University Hospital
š°š·Deagu, Korea, Republic of
Catholic University of Korea, Seoul St. Mary's Hospital
š°š·Seoul, Korea, Republic of
Samsung Medical Center
š°š·Seoul, Korea, Republic of
Seoul National University Hospital
š°š·Seoul, Korea, Republic of
Severance Hospital
š°š·Seoul, Korea, Republic of