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 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 cont

Trial Details

NCT ID
NCT05223816
Phase
PHASE2
Sponsor
Virogin Biotech Canada Ltd
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • VG161
  • Nivolumab Injection [Opdivo]
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Rochester, Minnesota, United States|44.02163,-92.4699

Key Eligibility Criteria

  • Signed written informed consent.
  • Males or females aged 18 years and older.
  • Performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1.
  • For subject in Cohort 2: cytologically confirmed advanced/metastatic or surgically unresectable HCC, with documented disease progression after at l…

For full eligibility, visit ClinicalTrials.gov.

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