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Tests treatment safety and results for Hepatocellular Carcinoma
Official 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
ClinicalTrials.gov ID: NCT05223816
What this study is testing
What is VG161?
VG161 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- For subject in Cohort 3: Histologically or cytologically confirmed advanced/metastatic or surgically unresectable ICC, with documented disease...
You likely can't join if
- Participation in any trial of any other investigational agent within the last 4 weeks prior to dosing. Wash out periods to be reviewed on a case by...
- Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators...
- people with any primary Central Nervous System (CNS) malignancy including glioma and current, active, progressing CNS malignancy, including...
- Major surgery within 14 days prior to dosing.
- Intercurrent serious infections within 28 days prior to Screening or treated systematically with antibiotics within 14 days prior to signing ICF.
- Life-threatening illness unrelated to cancer.
See the full eligibility 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...
- 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...
- For people in Cohort 1 and Cohort 4: should fulfill either 4) or 5).
- Liver function: Child-Pugh A-B for cohort 1 and 2.
- At least one measurable lesion per RECIST 1.1
- At least 1 injectable lesion; ≥15 mm in longest diameter and deemed injectable as per Investigator's discretion. people with deep or visceral lesions (such as hepatic or intraperitoneal lymph nodes) that can be safely...
- Participation in any trial of any other investigational agent within the last 4 weeks prior to dosing. Wash out periods to be reviewed on a case by case basis with Medical Monitor, as required.
- Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or...
- people with any primary Central Nervous System (CNS) malignancy including glioma and current, active, progressing CNS malignancy, including carcinomatosis meningitis are excluded. people with treated brain metastases...
- Major surgery within 14 days prior to dosing.
- Intercurrent serious infections within 28 days prior to Screening or treated systematically with antibiotics within 14 days prior to signing ICF.
- Life-threatening illness unrelated to cancer.
- Active Herpes infection.
- Treatment with antiviral agents within 14 days prior to dosing.
- Uncontrolled congestive heart failure.
- Known to test positive for human immunodeficiency virus (HIV) or syphilis.
- Active infection including hepatitis B (HBV) or hepatitis C (HCV) that currently under anti-virus treatment which can affect study drug treatment as per investigator's decision.
- Use of ganciclovir or acyclovir within 14 days prior to dosing.
- people with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to dosing. Inhaled or topical steroids...
- people who have been on systemic anticoagulants within 14 days prior to dosing and/or with International Normalized Ratio (INR) \> 1.5 x the upper limit of the reference range are excluded from this study.
- people with prior radiation therapy to the tumor lesion to be injected are excluded from the study, unless there is evidence of tumor progression in the most recent imaging, following completion of radiotherapy.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.