RecruitingPhase 1Phase 2NCT04665206

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients With Locally Advanced or Metastatic Solid Tumors


Sponsor

Vivace Therapeutics, Inc

Enrollment

434 participants

Start Date

Mar 24, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered, alone or in combination, once daily in patients with mesothelioma and/or metastatic solid tumors that are resistant to standard therapy or for which no effective standard therapy is available.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called VT3989 in patients with certain advanced cancers — specifically mesothelioma (a cancer often linked to asbestos exposure) and a type of lung cancer (NSCLC) with specific gene mutations. Researchers are exploring VT3989 on its own and in combination with other treatments. **You may be eligible if you:** - Have been diagnosed with malignant mesothelioma that has spread and have not yet received systemic (whole-body) cancer treatment, OR - Have advanced lung cancer (NSCLC) with specific mutations (exon 19 deletion or exon 21 L858R), with or without prior treatment with a drug called osimertinib - Have measurable disease on scans - Are in good enough health to participate (ECOG performance status 0–1) - Have adequate liver, kidney, and blood function **You may NOT be eligible if you:** - Have active brain metastases (cancer that has spread to the brain) or a primary brain tumor - Have had cancer spread to the lining around the brain or spinal cord Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVT3989

25, 50, 100, 150 or 200 mg capsules for oral administration.

DRUGNivolumab & Ipilimumab

Nivolumab infusion - 360 mg every 3 weeks, 30-minute intravenous infusion Ipilimumab infusion - 1 mg/kg every 6 weeks, 30-minute intravenous infusion

DRUGOsimertinib

40 or 80 mg tablets for oral administration

DRUGPemetrexed/Carboplatin

Pemetrexed infusion: 500 mg/m2 intravenous infusion Carboplatin infusion: AUC 5.0 intravenous infusion


Locations(12)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Virginia Cancer Specialists, PC

Arlington, Virginia, United States

Monash Health

Clayton, Victoria, Australia

Peter MacCullum Cancer Centre

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04665206


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