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NCT05223816 · ClinicalTrials.gov registry record · Phase 2
An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
A Phase 2 study of Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, sponsored by Virogin Biotech Canada.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
- 3
- Study locations
NCT05223816 is a Phase 2 study of Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma that is actively recruiting participants, run by Virogin Biotech Canada. The registered enrollment target is 97 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (62% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT05223816, a Phase 2 study of Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, is actively recruiting participants, sponsored by Virogin Biotech Canada.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
- 3
- Study locations
Study Summary
Safety Run-in Cohort (cohort 1): 10 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days. Monotherapy Cohorts (Cohort 2 and 3) Cohort 2 (HCC) This part is a single-agent, single one-dose level and single-arm design. Approximately 39 subjects will be enrolled in the study to receive VG161. In the first stage, 21 subjects will be enrolled. If there is only 1 or fewer subjects has been observed with objective response and no more than 12 (\<13) subjects have PFS longer than 3 months, the trial will be stopped. Otherwise, this study will continue to enter the second stage, and 18 additional subjects will be added, and the total number of trial subjects will reach 39. Cohort 3 (ICC) This part is a single-agent, single one-dose level and single-arm design. The trial will be carried out in two periods. In the first period, a total of 20 subjects will be enrolled. If there is only 1 or fewer response case in the 20 subjects, the trial will be stopped to investigate the efficacy of the IP, otherwise, subjects will continue to enter the second period, and 13 additional subjects will be added, and the total number of trial cases will reach 33. Cohort 4 (ICC and HCC) Combination with Nivolumab Combination cohort and subjects will receive VG161 at the same schedule as the monotherapy cohorts and 240 mg of intravenous Nivolumab on days 8 and 15 of each treatment cycle. The Nivolumab dose can be changed to 480 mg every 4 weeks after cycle one based on investigator's discretion.
Conditions Studied
Interventions
- DRUG Nivolumab Injection [Opdivo]
- DRUG VG161
Study Locations (3)
Arizona
- Mayo Clinic - Phoenix
Florida
- Mayo Clinic Florida - Jacksonville
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2024-01-24 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05223816
The ClinicalTrials.gov registry entry for NCT05223816 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (62% lower). The listed sponsor is Virogin Biotech Canada, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab Injection [Opdivo] is the first listed.
NCT05223816 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05223816 about?
NCT05223816 is a clinical study titled "An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma". Safety Run-in Cohort (cohort 1): 10 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days. Monotherapy Cohorts (Cohort 2 and 3) Cohort 2 (HCC) This part is a single-agent, single one-dose level and single-arm design. Approximately 39 subjects wi...
What is the current status of trial NCT05223816?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2024-01-24. Estimated completion is 2025-12-31.
What conditions does trial NCT05223816 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma.
What interventions are being tested in trial NCT05223816?
The interventions under investigation include: Nivolumab Injection [Opdivo] (DRUG), VG161 (DRUG).
Who is sponsoring clinical trial NCT05223816?
This trial is sponsored by Virogin Biotech Canada, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05223816 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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