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Virus Therapy
VG2025 + Nivolumab for Advanced Cancer
Phase 1
Recruiting
Research Sponsored by Virogin Biotech Canada Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1
Had an interval of ≥4 weeks (28 days) since exposure to immunotherapy, an interval of ≥3 weeks (21 days) since exposure to systemic chemotherapy, an interval of ≥6 weeks (42 days) since exposure to nitrosourea, and an interval of ≥4 weeks (28 days) since exposure to radiotherapy, prior to dosing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trialtests a new drug for advanced tumors. Doses are increased to find a safe dose, and DLT is monitored for 4 weeks.
Who is the study for?
Adults with advanced solid tumors that have not responded to standard treatments or for whom no standard treatment is available. Participants must be in relatively good physical condition (ECOG 0 or 1), not have serious heart conditions, infections, or autoimmune diseases, and agree to use effective contraception.Check my eligibility
What is being tested?
The trial tests VG2025 alone and combined with Nivolumab in patients with advanced malignant solid tumors. It's a Phase I study where doses are increased gradually to find the maximum safe amount. Patients receive bi-weekly injections directly into the tumor over a four-week period.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, general immune responses like fever or fatigue due to VG2025 activating the body's defenses, as well as typical side effects from immunotherapy such as skin rash, digestive issues, and flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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It's been over a month since my last cancer treatment.
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I have a skin or under-skin lump that's at least 15 mm wide or a visible lump in my lymph nodes.
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I am able to have children and have tested negative for pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events
MTD
Secondary outcome measures
ADA level of VG2025
DCR
DoR
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Monotherapy ArmExperimental Treatment1 Intervention
This is an open label trial using standard 3+3 design, in up to 24 HSV seropositive subjects. This rule-based design proceeds with cohorts of three patients.
Group II: Combination ArmExperimental Treatment2 Interventions
The starting dose of VG2025 in the combination cohorts will be a dose level lower than RP2D of monotherapy arm and Nivolumab will be administered intravenously as a flat dose of 240 mg every two weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab Injection [Opdivo]
2018
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Virogin Biotech Canada LtdLead Sponsor
1 Previous Clinical Trials
97 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I agree to avoid pregnancy during and 6 months after the study by abstaining or using strong contraception.I cannot stop my blood thinners safely for cancer treatment procedures.I haven't been in a drug trial with long-lasting effects in the last month.I will not have unprotected sex or will abstain from sex for 6 months after the study ends.I do not have a life-threatening illness unrelated to my cancer.I have had an organ transplant and take drugs to suppress my immune system.I haven't had serious infections or needed IV antibiotics in the last month.I have skin conditions without any current infections.I have not had major surgery in the last 14 days.I haven't had radiation on the tumor to be injected or it has grown since my last treatment.I have had an autoimmune disease in the last 2 years.I am 18 years old or older.I do not have a brain tumor or any active, worsening brain cancer.I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.I do not have an active Herpes or COVID-19 infection.I haven't taken antiviral medications in the last 14 days.My cancer has not responded to standard treatments, or there are none available.My tumor is not near major airways, blood vessels, or the spinal cord.It's been over a month since my last cancer treatment.I have a skin or under-skin lump that's at least 15 mm wide or a visible lump in my lymph nodes.I am able to have children and have tested negative for pregnancy.I do not have severe heart issues like recent heart attacks or uncontrolled heart rhythm problems.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy Arm
- Group 2: Combination Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are receiving access to this experimental research program?
"Affirmative. Clinicaltrials.gov furnishes data that confirms this clinical trial, which was first posted on November 1st 2022, is actively searching for participants to enrol in the study. There are 12 vacancies at a single medical centre currently available."
Answered by AI
Is the 3+3 design protocol considered sanctioned by the US Food and Drug Administration?
"The 3+3 design is still in its early stages, meaning the safety of this approach has only been evaluated to a limited extent. As such, our team at Power gave it a score of 1 out of 3."
Answered by AI
Are there any openings for participation in this research endeavor?
"The research study is still accepting participants, as evidenced on clinicaltrials.gov. The trial was initially made available to the public on November 1st 2022 and underwent its most recent update 3 days later."
Answered by AI
What are the objectives of this clinical research endeavor?
"The purpose of this research, to be completed in approximately one year's time, is determining the rate of Adverse Events. Additional objectives include assessing VG2025 Nab concentrations (neutralizing antibody [Nab]), IL-12/IL-15 levels within biopsied tumors and blood samples (interleukin level), as well as quantifying VG2025 ADA titers (anti-drug antibody [ADA])."
Answered by AI
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