RecruitingPhase 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

United States97 participantsStarted 2024-01-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion 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 least two lines of FDA approved systemic therapy, including immunotherapy or anti-angiogenesis therapy as the first line treatment and at least one regimen of the following agents as the second line: anti-angiogenesis agents, tyrosine kinase inhibitors or immunotherapy.
✓. For subject in Cohort 3: Histologically or cytologically confirmed advanced/metastatic or surgically unresectable ICC, with documented disease progression after chemotherapy as the first line systemic therapy. For patients with known IDH1 mutation, they must receive the appropriate targeted therapy with a IDH1 inhibitor and for patients with MSI-H tumors, they must receive immunotherapy with PD-1 inhibitors.
✓. For subjects in Cohort 1 and Cohort 4: should fulfill either inclusion criteria 4) or 5).
✓. Liver function: Child-Pugh A-B for cohort 1 and 2.
✓. At least one measurable lesion per RECIST 1.1

Exclusion criteria

What they're measuring

Safety in Cohort1

Timeframe: 12 months

ORR

Timeframe: 12 months

PFS

Timeframe: 3 months

Trial details

NCT IDNCT05223816

SponsorVirogin Biotech Canada Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-01

Contact for this trial

Naghmeh Esmaeili

7785589840 nesmaeili@virogin.com

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