What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often come with a range of side effects. Chemotherapy can cause myelotoxicity, leading to neutropenia, thrombocytopenia, and anemia, as well as non-hematologic toxicities like fatigue, nausea, and hand-foot syndrome. Targeted therapies, such as bevacizumab, may result in hypertension, proteinuria, and an increased risk of gastrointestinal perforation. Immunotherapy can lead to immune-related adverse events, including pneumonitis, colitis, and dermatitis. These side effects vary in severity and frequency depending on the specific agents used and the individual patient's response.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced or metastatic solid tumors. Notable approvals include immunotherapies such as pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways, and ipilimumab, which targets CTLA-4. Targeted therapies like VEGFR inhibitors (e.g., axitinib, cabozantinib) and PARP inhibitors (e.g., olaparib, niraparib) have also been approved for various solid tumors. These treatments have shown efficacy in managing advanced cancers by targeting specific molecular pathways involved in tumor growth and survival.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: 1) GD2-CAR T cell therapy for H3K27M-mutated diffuse midline gliomas, 2) ONC201, a selective DRD2 antagonist, for recurrent glioblastoma, 3) Pembrolizumab plus chemotherapy for metastatic non-small-cell lung cancer, 4) Atezolizumab in combination with chemotherapy for non-small-cell lung cancer, and 5) Cabozantinib for medullary thyroid cancer.

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Virus Therapy

VT1021 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Vigeo Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Dose Expansion Phase - Triple Negative Breast Cancer: Patients with confirmed diagnosis of metastatic TNBC must have received ≤ 3 prior lines of therapy for metastatic disease

Dose Expansion Phase - Glioblastoma: Patients with confirmed relapsed or refractory glioblastoma must have received ≤2 prior lines of systemic therapy

Must not have

Requirement to palliative radiotherapy to lesions that are defined as target lesions by RECIST criteria at the time of study entry

History of a major surgical procedure or a significant traumatic injury within 14 days prior to commencing treatment, or the anticipation of the need for a major surgical procedure during the course of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called VT1021 in patients with advanced cancers that have not responded to other treatments. The study will identify the best dose and then test it in specific types of cancer like ovarian, pancreatic, and breast cancer. The goal is to see if VT1021 can help stop or slow down the growth of these cancers.

Who is the study for?

This trial is for adults with advanced solid tumors where standard treatments won't cure them. Specific groups include those with certain ovarian, pancreatic, triple negative breast cancer (TNBC), glioblastoma, or CD36-high cancers who've had a limited number of prior therapies. Participants must be in fair health based on ECOG scale and agree to contraception use.

What is being tested?

The study tests VT1021's effects on various advanced solid tumors. It's an open-label Phase I trial meaning everyone gets the drug and there’s no placebo group. The focus is on how safe it is and what dose might work best across different types of cancer.

What are the potential side effects?

As this is an early-phase trial for VT1021, specific side effects aren’t listed but may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection, organ inflammation among others depending on individual patient response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have triple negative breast cancer and received 3 or fewer treatments for it after it spread.

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I have glioblastoma and have had 2 or fewer treatments for it.

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I can take care of myself and am up and about more than half of my waking hours.

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I have pancreatic cancer and have had 2 or fewer previous treatments.

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I haven't had chemotherapy or radiation for at least 21 days, or 12 weeks if I have glioblastoma.

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My cancer does not respond to or I cannot tolerate current treatments.

Exclusion Criteria

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

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I need radiation for specific cancer spots as per my study entry.

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I haven't had major surgery or significant injury in the last 14 days and don't expect any during the study.

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I am not currently receiving any other cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Identify recommended phase 2 dose by measuring incidence of dose limiting toxicities at increasing dose levels. Determine the safety and tolerability of VT1021 in ovarian, pancreatic, triple negative breast cancer, glioblastoma and CD36 high cohort.

Secondary study objectives

To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of AUC0-t

To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of AUC0-∞

To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of Cmax

+6 more

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: VT1021Experimental Treatment1 Intervention

Escalating doses of VT1021 to determine RP2D

0 / 9Eligibility 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 chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapy involves drugs designed to specifically target molecular pathways critical for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy leverages the body's immune system to recognize and destroy cancer cells, often by inhibiting checkpoints that prevent immune activation. These mechanisms are crucial for solid tumor patients as they offer different strategies to control tumor growth, improve survival rates, and potentially reduce treatment-related toxicity.

Current trends and future directions in the genetic therapy of human neoplastic disease.