What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly those involving immunotherapy and oncolytic viruses like VG2025, often lead to immune-related adverse events (irAEs). These can include colitis, dermatitis, hepatitis, and various endocrinopathies such as thyroiditis or adrenal insufficiency. Patients may also experience general side effects like fatigue, fever, and infusion reactions. It is crucial to monitor and manage these side effects promptly to ensure patient safety and treatment efficacy.

What prior FDA approvals exist?

The FDA has approved several immunotherapy agents for the treatment of solid tumors. Notable examples include pembrolizumab and nivolumab, both of which are immune checkpoint inhibitors targeting PD-1, and have been approved for various cancers such as melanoma and non-small cell lung cancer. Additionally, ipilimumab, an anti-CTLA-4 antibody, has been approved for melanoma. Oncolytic virus therapy, such as talimogene laherparepvec (T-VEC), has also received FDA approval for the treatment of melanoma. These therapies work by stimulating the immune system to target and destroy cancer cells.

What other types of research exist?

Promising alternatives to VG2025 for solid tumor patients include: 1) Nivolumab and Ipilimumab combination therapy, which has shown efficacy in various solid tumors including renal cell carcinoma and melanoma. 2) Pembrolizumab, a PD-1 inhibitor, which has demonstrated significant survival benefits in multiple solid tumors. 3) Atezolizumab plus Bevacizumab, particularly for renal cell carcinoma, as evidenced by the IMmotion151 trial. 4) Teclistamab, a bispecific antibody targeting B-cell maturation antigen, showing promise in multiple myeloma and potentially applicable to solid tumors.

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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

Must not have

Subjects who have been on systemic anticoagulants and cannot safely hold anticoagulation for planned intratumoral injections and study procedures

Participation in any previous immunotherapy trial or any trial of any other investigational agent if half-life is more than 5 days within the last 4 weeks prior to dosing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called VG2025, alone or combined with Nivolumab, in patients with advanced malignant solid tumors. VG2025 is injected directly into tumors to kill cancer cells, while Nivolumab helps the immune system fight cancer. The goal is to find effective treatments for patients who have not responded to standard therapies.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot stop my blood thinners safely for cancer treatment procedures.

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I haven't been in a drug trial with long-lasting effects in the last month.

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I do not have a life-threatening illness unrelated to my cancer.

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I have had an organ transplant and take drugs to suppress my immune system.

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I haven't had serious infections or needed IV antibiotics in the last month.

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I have not had major surgery in the last 14 days.

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I do not have a brain tumor or any active, worsening brain cancer.

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I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.

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I do not have an active Herpes or COVID-19 infection.

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I do not have severe heart issues like recent heart attacks or uncontrolled heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events

MTD

Secondary study objectives

ADA level of VG2025

DCR

DoR

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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 of 1.0 x108 PFU for combination cohort 1 on days 1 and 15 of every cycle. Combination cohort 2 will be dosed at 1.0 x108 PFU on Day 1 and either Day 2 or 3 in cycle 1 and 2. Day 1 only in subsequent cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab Injection [Opdivo]

2019

Completed Phase 2

~160

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include immunotherapy and oncolytic viruses. Immunotherapy, such as checkpoint inhibitors (e.g., nivolumab), works by stimulating the body's immune system to recognize and attack cancer cells. Oncolytic viruses, like VG2025, are engineered to selectively infect and kill cancer cells while also stimulating an anti-tumor immune response. These treatments are significant for solid tumor patients because they offer a targeted approach that can potentially overcome resistance to traditional therapies, reduce tumor burden, and improve survival outcomes.

Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.