What side effects are associated with this type of intervention?

Common treatments for cancer, such as immunotherapies and chemotherapies, have a range of side effects. Immune checkpoint inhibitors like nivolumab and ipilimumab can cause skin reactions, endocrine events, pneumonia, diarrhea, and serious adverse reactions like pneumonitis and respiratory failure. Chemotherapy often leads to cytopenias, infections, nausea, vomiting, and hair loss. Oncolytic virus therapies, which are designed to selectively target and destroy cancer cells while stimulating an immune response, may share some of these side effects, including immune-related adverse events and flu-like symptoms.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for cancer treatment, which are related to the immune activation aspect of NG-641. For example, pembrolizumab and nivolumab, which target PD-1, are approved for various cancers including melanoma, non-small cell lung cancer, and gastric cancer. Additionally, ipilimumab, targeting CTLA-4, is approved for melanoma. These drugs enhance the immune system's ability to fight cancer. While specific oncolytic virus therapies like NG-641 are not mentioned in the provided context, the approval of these immune checkpoint inhibitors highlights the FDA's support for treatments that leverage the immune system to combat cancer.

What other types of research exist?

Promising novel alternatives to NG-641 for cancer treatment in 2024 include: 1) Interleukin-2 (IL-2) based therapies, which enhance the immune response against tumors. 2) PD-1/PD-L1 inhibitors like pembrolizumab and avelumab, which have shown efficacy in various cancers by blocking immune checkpoints. 3) CAR-T cell therapies, which involve modifying a patient's T cells to better target cancer cells. 4) Combination therapies involving immune checkpoint inhibitors and other agents, such as nivolumab plus ipilimumab, which have demonstrated improved outcomes in several cancers. 5) Genetically modified tumor vaccines, which stimulate the immune system to attack cancer cells. These alternatives offer different mechanisms of action and potential benefits for cancer patients.

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Virus Therapy

NG-641 for Advanced Cancer (STAR Trial)

Phase 1

Waitlist Available

Led By Haesong Park, MD

Research Sponsored by PsiOxus Therapeutics Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study treatment visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called NG-641 to see if it is safe for patients with advanced or spreading epithelial tumors. The treatment is given through an IV, and researchers are trying to find the best dose.

Who is the study for?

This trial is for adults with advanced epithelial cancers that have failed standard treatments or have no standard options left. Participants must be expected to live at least 6 months, have tumors that can be biopsied safely, and function well in daily life (ECOG status 0-1). They should not have had certain vaccines, major surgeries, or specific treatments recently and must not have active infections or severe autoimmune diseases.

What is being tested?

The trial is testing NG-641, a new type of therapy designed to target cancer cells selectively. It's the first time this treatment is being used in humans. The main goal is to see how safe it is and how well patients tolerate it when given to those with metastatic or advanced epithelial tumors.

What are the potential side effects?

While the side effects of NG-641 are still being studied as this is its first use in humans, potential risks may include typical reactions related to immune therapies such as inflammation in organs, infusion-related symptoms, fatigue, digestive issues and increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study treatment visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study treatment visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study treatment visit 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 (safety and tolerability) in study NG-641

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: IntravenousExperimental Treatment1 Intervention

Phase 1a dose escalation: one cycle of treatment. Phase 1a dose optimisation: up to 8 cycles of treatment

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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

Cancer treatments work through various mechanisms to target and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, while immunotherapy boosts the body's immune system to recognize and attack cancer cells. Targeted therapy involves drugs designed to target specific genetic mutations or proteins that drive cancer growth. Oncolytic virus therapy, like NG-641, uses genetically modified viruses to selectively infect and kill cancer cells (direct oncolysis) and stimulate an immune response against the tumor. These mechanisms are crucial for cancer patients as they offer multiple strategies to combat the disease, potentially leading to more effective and personalized treatment options.

Oncolytic immunovirotherapy for melanoma using vesicular stomatitis virus.