VT3989 for Mesothelioma

Recruiting at 12 trial locations

Overseen By Neelesh Sharma, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Vivace Therapeutics, Inc

Must not be taking: TEAD inhibitors

Disqualifiers: Active brain metastases, CNS tumors, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

336 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new drug, VT3989, for patients with mesothelioma or other advanced cancers that have not responded to standard treatments. The study will explore different doses of VT3989 and evaluate its effectiveness when combined with other cancer therapies. Individuals with advanced mesothelioma or certain other solid tumors who have not found success with other treatments might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how VT3989 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that VT3989 is likely to be safe for humans?

Earlier studies have shown that VT3989 is generally safe. Most side effects were mild, such as changes in urine test results. Over 200 patients with advanced solid tumors, including mesothelioma, have taken VT3989, and it was well-tolerated.

Researchers are testing VT3989 both alone and with other treatments. When combined with immunotherapy or targeted therapy, the goal is to find the right dose without causing serious side effects.

The treatment remains in the early testing stages, so researchers are still learning about its safety. However, its testing in humans suggests some confidence in its safety so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about VT3989 for mesothelioma because it offers a novel approach by targeting a specific cellular pathway known as the Hippo-YAP signaling pathway, which plays a crucial role in cell growth and survival. Unlike standard treatments such as pemetrexed and cisplatin, VT3989 can be used in combination with advanced therapies like immunotherapy (nivolumab/ipilimumab) and targeted therapy (osimertinib), potentially enhancing its effectiveness. This multi-faceted approach not only aims to improve patient outcomes but also offers hope for those with refractory or metastatic solid tumors, which are often resistant to current treatment options.

What evidence suggests that VT3989 might be an effective treatment for mesothelioma?

Research has shown that VT3989 may effectively treat mesothelioma, a type of cancer. In a study with 22 patients, seven experienced tumor shrinkage, and 12 maintained stable disease. This suggests that VT3989 might help control cancer growth. The treatment targets a specific part of cancer cells, potentially stopping them from growing or spreading. These early results offer promise for those considering this treatment option. Participants in this trial may receive VT3989 alone or in combination with immunotherapy (nivolumab/ipilimumab) or targeted therapy (osimertinib) as part of the different treatment arms. ^{1 2 5 6 7}

Who Is on the Research Team?

Neelesh Sharma, MD

Principal Investigator

Vivace Therapeutics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

I am not pregnant or breastfeeding.

I have active cancer spread to my brain.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

VT3989 is dosed orally in 21 or 28 day cycles to determine the maximum tolerated dose (MTD) using a 3 + 3 design

3-4 weeks per cycle

Multiple visits per cycle

Dose Expansion

Further evaluation of safety and preliminary antitumor activity at the recommended phase 2 dose(s) and schedule(s) with up to 6 cohorts

3-4 weeks per cycle

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VT3989

Trial Overview 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.

How Is the Trial Designed?

Group I: VT3989 Dose Escalation [Not Recruiting] Experimental Treatment 1 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 Expansion [Not Recruiting] Experimental Treatment 1 Intervention

VT3989 dosed in 21 or 28 day cycles in patients with refractory metastatic solid tumors or mesothelioma.

Group III: Combination [Recruiting] Experimental Treatment 3 Interventions

VT3989 dosed in 28 day cycles in patients with metastatic solid tumors or mesothelioma, in combination with immunotherapy (nivolumab/ipilimumab) or targeted therapy (osimertinib)

Who Is Running the Clinical Trial?

Vivace Therapeutics, Inc

Lead Sponsor

Trials

1

Recruited

340+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04665206

Study to Evaluate VT3989 in Patients With Metastatic Solid ... This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered, alone or ...

2. onclive.com onclive.com/view/fda-grants-fast-track-designation-to-vt3989-for-unresectable-mesothelioma

FDA Grants Fast Track Designation to VT3989 for ... This multicenter, open-label trial is enrolling patients with mesothelioma and/or metastatic solid tumors that are resistant to standard therapy ...

3. mdanderson.org mdanderson.org/newsroom/research-newsroom/esmo-2025--vt3989-continues-to-show-promising-early-results-in-p.h00-159780390.html

ESMO 2025: VT3989 continues to show promising early ... Of the 22 mesothelioma patients treated with the optimized dose levels, seven had partial responses and 12 had stable disease – a disease ...

4. cancernetwork.com cancernetwork.com/view/vt3989-receives-orphan-drug-designation-for-the-treatment-of-mesothelioma

VT3989 Receives Orphan Drug Designation for the ... An ongoing, open-label phase 1 study evaluating VT3989 in mesothelioma revealed positive early efficacy and encouraging safety with the agent.

5. fiercebiotech.com fiercebiotech.com/biotech/esmo-vivace-tunes-ph-3-after-midstage-mesothelioma-trial-hits-high-note

Vivace hits high note in midstage mesothelioma trial In an ongoing phase 1/2 trial of VT3989, seven out of 22 evaluated patients showed a partial response to treatment, meaning their tumors shrank ...

6. trial.medpath.com trial.medpath.com/clinical-trial/174598f071573464/nct04665206-vt3989-refractory-solid-tumors-mutant-nf2

Study to Evaluate VT3989 in Patients With Metastatic Solid ... This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered, ...

7. curetoday.com curetoday.com/view/fda-grants-orphan-drug-status-to-vt3989-for-mesothelioma-treatment

FDA Grants Orphan Drug Status to VT3989 for ... The FDA awarded orphan drug designation to VT3989 for mesothelioma, supporting the experimental cancer treatment's development.