NCT05595473Active, not recruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Hepatocellular Carcinoma
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 7 Sept 2022
- Start date
- 29 Jul 2022
- Primary completion date
- Mar 2029
- Lead sponsor
- Rznomics, Inc.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05595473
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 42
- From 29 Jul 2022 to the primary completion date, Mar 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of hepatic encephalopathy
- Current or history of HIV positive
Other
- Moderate or severe ascites
- Carcinomas other than HCC
- Not suitable for inclusion judged by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Deagu | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.