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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Virogin Biotech Canada Ltd
Study ID
NCT05223816
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VG161 — DRUG
    Name: VG161 (Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) Concentration/Content: ≥1×107 PFU/mL; 1.0 mL/vial. Actual titer will be recorded on Certificate of Analysis. Composition: VG161,50 mM Tris-HCl, 150mM NaCl, \<5% glycerol Route of Administration: Intratumoral injection or image guided intratumoral injections.
  • Nivolumab Injection [Opdivo] — DRUG
    immunotherapy treatment

Study Details

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.

Key Dates

Start date
Jan 24, 2024
Status verified
Aug 2024
Primary completion
Oct 1, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
97 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Run-in Cohort
    10 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days.
  • Experimental: Cohort 2 (HCC)
    21 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days.
  • Experimental: Cohort 3 (ICC)
    20 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days.
  • Experimental: Cohort 4 (HCC and ICC)
    Up to 12 patients will be treated with IT injection of VG161 ar dose level of 1.0x10E8 PFU x 3 days. and Nivolumab per approved label.

Primary Outcome Measure

Safety in Cohort1 [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054
Mitesh Borad
Mayo Clinic FloridaJacksonvilleFlorida32224
Hani Babiker, MD
Mayo ClinicRochesterMinnesota55905
Lionel Kankeu-Fonkoua

Find similar trials in Phoenix, AZ

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Mayo Clinic· Phoenix, AZMayo Clinic Florida· Jacksonville, FLMayo Clinic· Rochester, MN

Related Studies