Hepatocellular Carcinoma (HCC)
Conditions
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).
Interventions
DRUGRZ-001 Dose 1
RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab
DRUGRZ-001 Dose 2
RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab
DRUGRZ-001 Dose 3
RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab
Sponsors
Rznomics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
| 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 |
Countries
South Korea
Contacts
Primary ContactRznomics, Inc.
Outcome results
None listed