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VT3989 for Mesothelioma

Phase 1

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 30 months

Awards & highlights

Study Summary

This trial is testing a new drug for people with cancer that has spread to the lining of the lungs or other parts of the body. The goal is to see if it is safe and works well.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of Dose Limiting Toxicity

Occurrence of General Toxicity

Secondary outcome measures

Pharmacokinetic Evaluation - Cmax

Pharmacokinetic Evaluation - Half-life

Pharmacokinetic Evaluation - Tmax

+1 more

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vivace Therapeutics, IncLead Sponsor

Media Library

VT3989 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04665206 — Phase 1

Mesothelioma Research Study Groups: VT3989 Dose Escalation, Dose Expansion

Mesothelioma Clinical Trial 2023: VT3989 Highlights & Side Effects. Trial Name: NCT04665206 — Phase 1

VT3989 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04665206 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide a current status on the availability of this research to participants?

"Affirmative, the clinical trial is currently recruiting patients. This investigation was first launched on March 24th 2021 and underwent its last revision in late October of this year. 80 individuals need to be recruited from 5 different sites for successful completion."

Answered by AI

What aims have been established to evaluate the success of this research?

"The primary endpoint of this trial, monitored over 21 days, is the occurrence of general toxicity. Other secondary objectives include determining tumor response through RECIST v1.1 or modified RECIST v1.1, assessing VT3989's half-life in plasma concentration after peak levels are reached and evaluating Cmax (peak plasma concentrations) for VT3989."

Answered by AI

Could you outline the safety profile of VT3989?

"The safety of VT3989 is estimated to be at a level 1 due to its status as a Phase 1 trial; thus, the data supporting both efficacy and safety are limited."

Answered by AI

How many participants are currently being admitted to this research program?

"This clinical trial necessitates the enrollment of 80 eligible patients from across multiple states. At present, there are opportunities for participation in MD Anderson Cancer Center situated in Houston and University of Chicago Medical Centre located in Chicago."

Answered by AI

In how many distinct venues is this trial conducted?

"Currently, the trial is in progress at 5 different healthcare facilities, including those located in Houston, Chicago and Boston. To reduce travel time/costs if you decide to take part, it is recommended that you select a facility closest to your residence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 Gene Mutations

2021. "Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 Gene Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04665206.

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