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Clinical Trials in the USA / NCT04665206
Recruiting Phase 1/2

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

NCT04665206 · tracked via the Priya Life Science USA tracker
Sponsor
Vivace Therapeutics, Inc
Phase
Phase 1/2
Started
2021-03-24
Last updated
2026-04-02

Condition(s) studied

Solid Tumor, AdultMesotheliomaNSCLC

Investigational drug(s) / intervention(s)

VT3989Nivolumab & IpilimumabOsimertinibPemetrexed/Carboplatin

VT3989: 25, 50, 100, 150 or 200 mg capsules for oral administration.

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

Osimertinib: 40 or 80 mg tablets for oral administration

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
M Health Fairview University of Minnesota Medical Center Minneapolis Minnesota Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
NEXT Oncology San Antonio Texas Recruiting
Virginia Cancer Specialists, PC Arlington Virginia Recruiting
Monash Health Clayton Victoria Recruiting
Peter MacCullum Cancer Centre Melbourne Victoria Recruiting
Linear Clinical Research Nedlands Western Australia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04665206 on ClinicalTrials.gov ↗ ← All trials in the USA