VG161 in the Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
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.