OncoMatch/Clinical Trials/NCT05223816
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
Is NCT05223816 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including VG161 and Nivolumab for hepatocellular carcinoma.
Treatment: VG161 · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Cholangiocarcinoma
Biomarker criteria
Allowed: IDH1 mutation
For patients with known IDH1 mutation, they must receive the appropriate targeted therapy with a IDH1 inhibitor
Allowed: MSH2 MSI-H
for patients with MSI-H tumors, they must receive immunotherapy with PD-1 inhibitors
Disease stage
Required: Stage IV
advanced/metastatic or surgically unresectable HCC/ICC; at least one measurable lesion per RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immunotherapy or anti-angiogenesis therapy — first line
including immunotherapy or anti-angiogenesis therapy as the first line treatment
Must have received: anti-angiogenesis agent — second line
at least one regimen of the following agents as the second line: anti-angiogenesis agents, tyrosine kinase inhibitors or immunotherapy
Must have received: tyrosine kinase inhibitor — second line
at least one regimen of the following agents as the second line: anti-angiogenesis agents, tyrosine kinase inhibitors or immunotherapy
Must have received: immunotherapy — second line
at least one regimen of the following agents as the second line: anti-angiogenesis agents, tyrosine kinase inhibitors or immunotherapy
Must have received: chemotherapy — first line
disease progression after chemotherapy as the first line systemic therapy
Must have received: IDH1 inhibitor — after chemotherapy
For patients with known IDH1 mutation, they must receive the appropriate targeted therapy with a IDH1 inhibitor
Must have received: anti-PD-1 therapy — after chemotherapy
for patients with MSI-H tumors, they must receive immunotherapy with PD-1 inhibitors
Cannot have received: radiation therapy
Exception: unless there is evidence of tumor progression in the most recent imaging, following completion of radiotherapy
Subjects with prior radiation therapy to the tumor lesion to be injected are excluded from the study, unless there is evidence of tumor progression in the most recent imaging, following completion of radiotherapy.
Lab requirements
Liver function
child-pugh a-b for cohort 1 and 2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic · Phoenix, Arizona
- Mayo Clinic Florida · Jacksonville, Florida
- Mayo Clinic · Rochester, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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