VT3989 for Mesothelioma

Recruiting at9 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Vivace Therapeutics, Inc

Must not be taking: TEAD inhibitors

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

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Neelesh Sharma, MD

Principal Investigator

Vivace Therapeutics

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• VT3989 (Other)

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.

Participant Groups

Group I: VT3989 Dose Escalation 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 Experimental Treatment 1 Intervention

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

Group III: Combination 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+