NCT05223816 · Virogin Biotech Canada Ltd
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
What this study is about
Safety Run-in group of participants (group of participants 1): 10 patients will be treated with IT injection of VG161 in the group of participants 1 at dose level of 1.0x10E8 PFU x 3 days. treatment given alone Cohorts (group of participants 2 and 3) group of participants 2 (HCC) This part is a single-agent, single one-dose level and single-treatment group$1 design.
View original scientific description
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.
Interventions
DRUG
VG161
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.
DRUG
Nivolumab Injection [Opdivo]
immunotherapy treatment
Primary outcome measures
Safety in Cohort1
Time frame: 12 months
Occurrence and severity of AEs, SAEs (according to NCI CTCAE version 5.0) in Safety Run-in Cohort (cohort 1)
ORR
Time frame: 12 months
Objective response rate in HCC Cohort (Cohort 2) and ICC Cohort (Cohort 3)
PFS
Time frame: 3 months
Progression-free survival in HCC Cohort (Cohort 2)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Signed written informed consent. 2. Males or females aged 18 years and older. 3. Performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1. 4. 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. 5. 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 in
Where
- Phoenix, Arizona
- Jacksonville, Florida
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 9, 2024 · Source of record for eligibility and locations