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VT3989 for Metastatic Solid Tumors and Mesothelioma

This study is testing a new drug called VT3989, alone or with other treatments like Nivolumab & Ipilimumab, Osimertinib, or Pemetrexed/Carboplatin. It's for adults with metastatic solid tumors (cancers that have spread) or mesothelioma (a type of cancer that forms in the lining of the lungs, abdomen, or heart). The main goals are to understand the safety of VT3989 and see how well it's tolerated, especially looking for any serious side effects in the first 21 days and throughout the study. This study is open to adults aged 18 and older. The current status of this study is unclear, and it plans to enroll 434 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves different parts, including dose escalation to find the best dose and dose expansion to further evaluate safety and preliminary anti-tumor activity.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
General toxicity will be measured through study completion, which is an average of 30 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04665206

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Vivace Therapeutics, Inc
~434 participants
Updated 2026-04-02 on ClinicalTrials.gov
What's tested:VT3989Nivolumab & IpilimumabOsimertinibPemetrexed/Carboplatin

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Dose Limiting Toxicity
Measured over over the first 21 days of dosing
+1 more outcome measured

Conditions

Solid Tumor, Adult
Mesothelioma
NSCLC

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Where it's being run

12 sites across 9 states
Massachusetts2
Texas2
Victoria2
California1
Illinois1
Minnesota1
New York1
Virginia1

Study leadership

  • Neelesh Sharma, MD · STUDY_DIRECTOR · Vivace Therapeutics

Who to contact

Heather Fritz
[email protected]
650-627-7437
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Part 3 Combination Cohort A: Patients with pathologically diagnosed, metastatic or unresectable malignant mesothelioma (including both pleural and non-pleural) who have not received systemic therapy.
Part 3 Combination Cohort B: Patients with pathologically diagnosed incurable locally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19 deletions or exon 21 L858R mutations, with or without prior treatment with Osimertinib.
Part 3 Combination Cohort C: Patients with pathologically diagnosed metastatic or unresectable malignant pleural mesothelioma who have not received systemic chemotherapy.
Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solid tumors or modified RECIST v1.1 for malignant pleural mesothelioma. mRECIST may be used for pleural extension of non-pleural mesothelioma or for mixed pleural and peritoneal (or other) mesothelioma.
ECOG: 0-1.
Adequate organ functions, including the liver, kidneys, and hematopoietic system.

Exclusion

Active brain metastases or primary CNS (central nervous system) tumors.
History of leptomeningeal metastases
Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Known HIV positive or active Hepatitis B or Hepatitis C
Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents.
Corrected QT (QTcF) interval \> 470 msec (using Fridericia's correction formula).
Additional active malignancy that may confound the assessment of the study endpoints
Women who are pregnant or breastfeeding
Prior treatment with TEAD inhibitor.

What this trial measures

  • Occurrence of Dose Limiting Toxicityover the first 21 days of dosing

    Incidence of Adverse and Serious Adverse Events

  • Occurrence of General Toxicitythrough study completion, an average of 30 months

    Incidence of Adverse and Serious Adverse Events, Discontinuations due to Adverse Events and general safety evaluations