What side effects are associated with this type of intervention?

Common treatments for mesothelioma, such as chemotherapy, targeted therapy, and immunotherapy, often have a range of side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased risk of infection. Targeted therapies, which may include drugs like VT3989, can lead to side effects such as fatigue, skin reactions, and gastrointestinal issues. Immunotherapy side effects often include fatigue, skin rashes, and flu-like symptoms. It is important for patients to discuss potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for mesothelioma, including pemetrexed in combination with cisplatin, which targets folate-dependent enzymes, and nivolumab, an immune checkpoint inhibitor targeting PD-1. Additionally, investigational therapies such as nintedanib, a tyrosine kinase inhibitor, and vorinostat, a histone deacetylase inhibitor, have been studied but did not show significant survival benefits. These treatments focus on disrupting cancer cell growth and enhancing immune response, similar to the investigational approach of VT3989.

What other types of research exist?

Promising novel alternatives to VT3989 for Mesothelioma patients include SLV-11199, which inhibits heme oxygenase activity and shows anticancer effectiveness by decreasing cell viability and migration, and PM060184, a tubulin binding agent that overcomes P-glycoprotein mediated resistance and inhibits tubulin polymerization. Both agents demonstrate significant antitumor activity and could be considered for further development in treating Mesothelioma.

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VT3989 for Mesothelioma

Phase 1 & 2

Recruiting

Research Sponsored by Vivace Therapeutics, Inc

Eligibility Criteria Checklist

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

Must have

Part 1: pathologically diagnosed metastatic solid tumor or advanced malignant pleural mesothelioma that has progressed on or after standard of care therapy with evaluable or measurable disease per RECIST v1.1

Part 2: pathologically diagnosed advanced malignant pleural mesothelioma with NF2 mutations (Cohort 1) or metastatic solid tumors with NF2 mutation (Cohort 2), for which there is no further standard of care therapy available with measurable disease per RECIST v1.1 for solid tumors or modified RECIST v1.1 for malignant pleural mesothelioma

Must not have

Clinically significant cardiovascular disease

Women who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, VT3989, for safety and effectiveness in patients with certain types of cancer that don't respond to other treatments. Researchers aim to find the best dose and see if the drug can help control the cancer.

Who is the study for?

This trial is for adults with advanced mesothelioma or metastatic solid tumors that have worsened after standard treatments. Participants must be in good physical condition (ECOG: 0-1) and have measurable disease. They can't join if they have active brain metastases, certain infections like HIV or hepatitis, serious heart issues, are pregnant/breastfeeding, or have another cancer that could affect results.

What is being tested?

The study tests VT3989's safety and effectiveness on patients with specific gene mutations linked to their cancer. It's an open-label trial where everyone gets the drug; doses will increase to find the right amount before expanding to more patients.

What are the potential side effects?

While not specified here, common side effects of new cancer drugs may include nausea, fatigue, skin reactions, blood count changes leading to increased infection risk or bleeding problems. The exact side effects of VT3989 will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread, worsened after treatment, and can be measured.

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I have advanced cancer with NF2 mutation and no standard treatments left.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

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

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I have a serious heart condition.

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I am not pregnant or breastfeeding.

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I have active cancer spread to my brain.

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I have had cancer spread to the lining of my brain and spinal cord.

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I do not have another cancer that could affect this study's results.

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I do not have ongoing serious infections needing long-term treatment.

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I am HIV positive or have active Hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 30 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

Occurrence of Dose Limiting Toxicity

Occurrence of General Toxicity

Secondary study objectives

Pharmacokinetic Evaluation - Cmax

Pharmacokinetic Evaluation - Half-life

Pharmacokinetic Evaluation - Tmax

+1 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: VT3989 Dose EscalationExperimental Treatment1 Intervention

VT3989 dosed orally in 21 or 28 day cycles. Patients will be enrolled into escalating dose levels during the Dose Escalation Phase

Group II: Dose ExpansionExperimental Treatment1 Intervention

VT3989 dosed in 21 or 28 day cycles in patients with refractory metastatic solid tumors or mesothelioma, with or without NF2 mutant tumors.

0 / 10Eligibility 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

The most common treatments for Mesothelioma include chemotherapy, targeted therapies, and investigational agents. Chemotherapy, such as pemetrexed combined with cisplatin, works by interfering with the DNA replication process, thereby inhibiting cancer cell growth. Targeted therapies, like nintedanib, aim to block specific molecules involved in tumor growth and angiogenesis, such as VEGFR, PDGFR, and FGFR. Investigational agents, including those similar to VT3989, are being studied for their potential to target specific genetic mutations or pathways involved in Mesothelioma. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment based on the tumor's specific characteristics, potentially improving outcomes and minimizing side effects.

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