Actively Recruiting
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
Led by Virogin Biotech Canada Ltd · Updated on 2024-08-09
97
Participants Needed
3
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VG161, an investigational drug, alone and in combination with Nivolumab for treating patients with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC). This phase IIa/IIb clinical trial aims to assess the safety, tolerability, and effectiveness of VG161 in different patient cohorts, including a safety run-in cohort, monotherapy cohorts for HCC and ICC, and a combination therapy cohort with Nivolumab. The trial involves multiple centers and includes patients with advanced-stage liver cancers who have undergone prior treatments. Participants receive intratumoral injections of VG161 at a specified dose level for three days in the safety run-in cohort and monotherapy cohorts. In the combination cohort, patients receive VG161 injections plus intravenous Nivolumab on days 8 and 15 of each treatment cycle, with possible dose adjustments after the first cycle. The study includes separate periods for enrollment and evaluation within each cohort, with planned stopping rules based on responses and progression-free survival to determine continuation or expansion of the trial groups. Throughout the study, participants undergo regular assessments including safety monitoring, tumor response evaluations, and collection of blood samples to measure VG161 concentrations, immune markers, and viral shedding up to 12 months. Researchers will evaluate outcomes such as objective response rate, progression-free survival at three months, overall survival, duration of response, and immunogenicity. The total involvement may last up to a year, with close follow-up to assess treatment effects and patient safety.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent.
- Male or female aged 18 years and older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- For Cohort 2: confirmed advanced/metastatic or unresectable hepatocellular carcinoma with disease progression after at least two lines of FDA approved systemic therapy including immunotherapy or anti-angiogenesis therapy.
- For Cohort 3: confirmed advanced/metastatic or unresectable intrahepatic cholangiocarcinoma with disease progression after chemotherapy; patients with IDH1 mutation must have received targeted therapy; patients with MSI-H tumors must have received PD-1 inhibitor immunotherapy.
- For Cohorts 1 and 4: meet either Cohort 2 or Cohort 3 criteria.
- Liver function Child-Pugh A-B for Cohorts 1 and 2.
- At least one measurable lesion per RECIST 1.1.
- At least one injectable lesion ≥15 mm in longest diameter, suitable for intratumoral injection.
You will not qualify if you...
- Participation in another investigational trial within 4 weeks prior to dosing.
- Tumors in mucosal areas or near critical structures that risk occlusion or compression.
- Primary central nervous system malignancy or active, progressing CNS disease; treated brain metastases allowed if stable for 4 weeks and off steroids.
- Major surgery within 14 days prior to dosing.
- Serious infections within 28 days prior to screening or recent antibiotic treatment.
- Life-threatening illness unrelated to cancer.
- Active herpes infection or recent antiviral treatment.
- Uncontrolled congestive heart failure.
- Known positive for HIV or syphilis.
- Active hepatitis B or C under antiviral treatment affecting study drug use.
- Use of ganciclovir or acyclovir within 14 days prior to dosing.
- Need for systemic corticosteroids >10 mg prednisone equivalent or immunosuppressive drugs within 14 days prior to dosing.
- Systemic anticoagulant use within 14 days prior to dosing or elevated INR.
- Prior radiation therapy to the tumor to be injected unless progression is documented.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 days
Participants receive intratumoral injections of VG161 for 3 consecutive days to evaluate safety and tolerability.
3 visits (in-person) for VG161 injections
Duration - Up to 12 months
Participants receive intratumoral injections of VG161 and, for some, Nivolumab according to approved dosing schedules to treat hepatocellular carcinoma or intrahepatic cholangiocarcinoma.
Multiple visits for injections and assessments over 12 months
Trial Site Locations
Total: 3 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
N
Naghmeh Esmaeili
M
Mike Teng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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