IDOV-Immune for Cancer

Recruiting at 6 trial locations

Overseen By Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ViroMissile, Inc.

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Hepatitis, HIV, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IDOV-Immune, which uses a virus to target and destroy cancer cells in individuals with advanced solid tumors unresponsive to other treatments. The main goal is to determine the treatment's safety and identify the highest dose that can be administered without severe side effects. Participants receive one dose through an IV and are closely monitored to observe their bodies' and tumors' reactions. Individuals who have tried standard treatments for their cancer but still experience tumor growth might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on medications for active infections, autoimmune diseases, or require chronic immunosuppressive therapy, you may not be eligible to participate.

Is there any evidence suggesting that IDOV-Immune is likely to be safe for humans?

Research shows that oncolytic viruses like IDOV-Immune target and destroy cancer cells while mostly sparing healthy ones. This means they generally have little effect on normal, healthy cells. Earlier studies with similar treatments have shown promise in not only attacking cancer cells but also boosting the immune system's ability to fight tumors.

Regarding safety, this trial is in its early stages, focusing on the treatment's safety and potential side effects. This marks the first time IDOV-Immune is tested in humans, making safety a primary goal. Researchers will closely monitor participants for any side effects after treatment. IDOV-Immune is designed to balance attacking cancer with minimizing negative effects on the body. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about IDOV-Immune because it represents a novel approach to cancer treatment through its use of an oncolytic vaccinia virus. Unlike traditional therapies, such as chemotherapy or radiation, which target all rapidly dividing cells, IDOV-Immune specifically targets cancer cells by infecting and destroying them from within. This targeted mechanism not only has the potential to reduce damage to healthy cells but also to stimulate the body's immune system to recognize and fight cancer more effectively. By offering a more precise attack on cancer cells, IDOV-Immune could lead to fewer side effects and improved outcomes for patients.

What evidence suggests that IDOV-Immune might be an effective treatment for advanced solid tumors?

Research has shown that oncolytic viruses, such as IDOV-Immune, hold promise in fighting cancer by attacking and destroying cancer cells while boosting the immune system. Studies have found that these viruses can specifically infect tumor cells, leading to their destruction. Early findings suggest that oncolytic vaccinia viruses, like IDOV-Immune, may help shrink tumors. Evidence also indicates that combining these viruses with other cancer treatments can enhance their effectiveness. Initial results from previous studies demonstrate potential benefits, but further research is needed to confirm these findings. Participants in this trial will receive IDOV-Immune in a dose-escalation design to assess safety and preliminary antitumor activity. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults with advanced solid tumors, such as various cancers (sarcoma, bladder, lung, prostate, renal cell carcinoma and more), that haven't improved with standard treatments can join. Specific eligibility details are not provided.

Inclusion Criteria

Agreement to use effective contraception during treatment and for 3 months after

Ability to provide informed consent and comply with study requirements

Measurable disease per RECIST v1.1

Exclusion Criteria

I am currently fighting an infection that needs treatment.

Any medical or psychiatric condition that could interfere with study participation

I do not have active or untreated brain metastases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous (IV) infusion of IDOV-Immune on Day 1 of a 28-day treatment cycle, with frequent safety assessments and monitoring

28 days

Multiple visits for safety assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival and overall survival

Up to 12 months

Dose Escalation

Participants are enrolled in cohorts to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) through a dose-escalation design

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• IDOV-Immune

Trial Overview

The trial is testing IDOV-Immune, an oncolytic virus therapy given via IV infusion to destroy cancer cells and possibly boost the immune system's response against tumors. It aims to find the safest high dose and observe how it affects the body and cancer.

How Is the Trial Designed?

Group I: IDOV-Immune Dose Escalation Arm Experimental Treatment 1 Intervention

Participants in this arm will receive a single intravenous (IV) infusion of IDOV-Immune, an investigational oncolytic vaccinia virus, on Day 1 of a 28-day treatment cycle. The study will follow a dose-escalation design, with each successive cohort receiving an increased dose based on safety data and observed dose-limiting toxicities (DLTs). Following dose escalation, expansion cohorts may be enrolled at selected dose levels to further assess safety and preliminary antitumor activity.

Who Is Running the Clinical Trial?

ViroMissile, Inc.

Lead Sponsor

Published Research Related to This Trial

Immune checkpoint inhibitors (ICIs) can lead to immune-related adverse events (irAEs) due to their mechanism of action, necessitating a multidisciplinary approach for effective patient management, as highlighted by 30 real-world pharmacovigilance studies.

These studies have provided valuable insights into the patterns, kinetics, and fatality rates of various irAEs, emphasizing the need for oncologists to understand both the strengths and limitations of this data for better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons to be Learnt from Real-World Studies on Immune-Related Adverse Events with Checkpoint Inhibitors: A Clinical Perspective from Pharmacovigilance. Raschi, E., Gatti, M., Gelsomino, F., et al.[2021]

In cohort A, which included 30 patients with metastatic melanoma, the combination of an IDO/PD-L1 vaccine and nivolumab resulted in an impressive overall response rate of 80%, with 50% achieving a complete response and a median progression-free survival of 25.5 months.

Cohort B, where the vaccine was added to patients already on anti-PD-1 therapy, showed limited efficacy with only stable disease in 2 out of 10 patients and a median progression-free survival of just 2.4 months, indicating that the combination may not be effective for those with progressive disease during anti-PD-1 treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of anti-PD-1 naïve patients with metastatic melanoma treated with IDO/PD-L1 targeting peptide vaccine and nivolumab. Lorentzen, CL., Kjeldsen, JW., Ehrnrooth, E., et al.[2023]

Immunotherapy, particularly with checkpoint inhibitors like anti-PD1 and anti-CTLA-4 agents, has shown high response rates in cancer treatment, but it can lead to a variety of immune-related adverse events that are not selective.

Real-world data suggests that the characteristics and management of these adverse events may differ from clinical trial recommendations, highlighting the need for tailored approaches in using corticosteroids and other treatments for severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicities from immunotherapy: From clinical trials to real-world clinical practice. Riveiro-Barciela, M., Trallero-Araguás, E., Martínez-Valle, F.[2021]

In a phase 1/2 study involving 30 patients with metastatic melanoma, the combination of the immune-modulatory vaccine (IO102/IO103) with nivolumab showed a high objective response rate of 80%, with 43% of patients achieving complete responses.

The safety profile of the combination therapy was comparable to nivolumab alone, and after a median follow-up of nearly 23 months, the median progression-free survival was 26 months, indicating promising efficacy and tolerability for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1/2 trial of an immune-modulatory vaccine against IDO/PD-L1 in combination with nivolumab in metastatic melanoma. Kjeldsen, JW., Lorentzen, CL., Martinenaite, E., et al.[2023]

The study developed a framework using real-world data from the FDA's Adverse Event Reporting System to detect and filter immune-related adverse events (irAEs) associated with six FDA-approved immune checkpoint inhibitors, identifying 94 positive signals.

Out of these signals, 31 (33%) were classified as potentially new irAEs, highlighting the framework's effectiveness in discovering novel safety concerns that may not be documented in existing drug labels or literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detecting and Filtering Immune-Related Adverse Events Signal Based on Text Mining and Observational Health Data Sciences and Informatics Common Data Model: Framework Development Study. Yu, Y., Ruddy, K., Mansfield, A., et al.[2020]

Cancer immunotherapies, particularly anti-CTLA4 and anti-PD1/PD-L1, are becoming more common in treatment regimens, leading to increased exposure of patients to immune-related adverse events (irAEs).

These immunotherapies can activate the immune system to fight tumors effectively, but they also have a unique toxicity profile that can cause autoimmune reactions, necessitating changes in clinical management practices to address these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of adverse events associated with cancer immunotherapy]. Laparra, A., Champiat, S., Michot, JM., et al.[2021]

Citations

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NCT06910657 | IDOV-Immune for Advanced Solid Tumors

IDOV-Immune is a genetically engineered oncolytic vaccinia virus designed to selectively infect and destroy tumor cells while stimulating the immune system.

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Here, we present the first-in-human results from a phase I clinical trial evaluating the safety, PK, PD and preliminary efficacy of intravenous ...

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pmc.ncbi.nlm.nih.gov/articles/PMC10811104/

Oncolytic vaccinia virus and cancer immunotherapy - PMC

OVT is an effective form of immunotherapy that has been used to treat cancer. As previously mentioned, OVs can selectively kill tumor cells, ...

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frontiersin.org

frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1272351/full

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Combining oncolytic VV therapy with other conventional cancer treatments has been shown to be synergistic and more effective than monotherapies.

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Remodeling of the tumor microenvironment using an engineered oncolytic vaccinia virus improves PD-L1 inhibition outcomes. Biosci Rep 2021;41 ...

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IDOV-Immune is a genetically engineered oncolytic vaccinia virus designed to selectively infect and destroy tumor cells while stimulating the immune system.

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Oncolytic viruses (OVs) are capable of replicating in cancer cells whilst having minimal impact on healthy cells. In addition to this, these viruses can be ...

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anzctr.org.au

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IDOV-Immune is a genetically engineered oncolytic vaccinia virus designed to selectively infect and destroy tumor cells while stimulating the ...

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IDOV-Immune for Advanced Solid Tumors - ClinicalTrials.Veeva

Oncolytic viruses have the potential for destroying cancer cells and activating anti-tumor immune responses. IDOV-Immune's multi-pronged design ...