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RECRUITING
NCT04665206
PHASE1/PHASE2

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

Sponsor: Vivace Therapeutics, Inc

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

434

Start Date

2021-03-24

Completion Date

2030-03-02

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

VT3989

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

DRUG

Nivolumab & Ipilimumab

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

DRUG

Osimertinib

40 or 80 mg tablets for oral administration

DRUG

Pemetrexed/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