Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

Last updated: October 24, 2025
Sponsor: Vivace Therapeutics, Inc
Overall Status: Active - Recruiting

Phase

1/2

Condition

Non-small Cell Lung Cancer

Mesothelioma

Treatment

VT3989

Nivolumab & Ipilimumab

Osimertinib

Clinical Study ID

NCT04665206
VT3989-001
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Part 3 Combination Cohort A: Patients with pathologically diagnosed, metastatic orunresectable malignant mesothelioma (including both pleural and non-pleural) whohave not received systemic therapy.

  • Part 3 Combination Cohort B: Patients with pathologically diagnosed incurablelocally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19deletions or exon 21 L858R mutations, with or without prior treatment withOsimertinib.

  • Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solidtumors or modified RECIST v1.1 for malignant pleural mesothelioma. mRECIST may beused for pleural extension of non-pleural mesothelioma or for mixed pleural andperitoneal (or other) mesothelioma.

  • ECOG: 0-1.

  • Adequate organ functions, including the liver, kidneys, and hematopoietic system.

Exclusion

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) requiringsystemic therapy

  • Known HIV positive or active Hepatitis B or Hepatitis C

  • Clinically significant cardiovascular disease

  • Corrected QT (QTcF) interval > 470 msec (using Fridericia's correction formula);except for Part 2 Expansion Cohort 3, the QTcF interval criteria is > 450 msec).

  • Additional active malignancy that may confound the assessment of the study endpoints

  • Women who are pregnant or breastfeeding

  • Prior treatment with TEAD inhibitor, except for EHE patients.

Study Design

Total Participants: 336
Treatment Group(s): 3
Primary Treatment: VT3989
Phase: 1/2
Study Start date:
March 24, 2021
Estimated Completion Date:
June 02, 2027

Study Description

Dose escalation (Part 1) will employ a traditional 3 + 3 design to assess safety of VT3989 in patients with metastatic solid tumors or mesothelioma. The 3 + 3 design will be implemented until the MTD or recommended phase 2 dose(s) and schedule(s) are determined. The MTD is defined as the highest dose level at which < 33% of patients experience a dose limiting toxicity (DLT) during the first cycle of the study (Cycle 1).

Dose Expansion (Part 2) will further evaluate the safety and assess preliminary antitumor activity at the recommended phase 2 dose(s) and schedule(s) with up to 6 cohorts. Expansion cohorts 1 and 2 will enroll patients with mesothelioma of any site origin with or without NF2 mutations. Expansion cohort 3 will enroll non-pleural mesothelioma patients. Expansion cohort 4 will enroll solid tumor patients with clearly inactivating NF2 mutations/alterations or YAP/TAZ gene rearrangements. Cohort 5 will enroll pleural mesothelioma patients.

Combination part (Part 3) includes two cohorts. Cohort A will enroll mesothelioma patients who will receive VT3989 in combination with immunotherapy (nivolumab plus ipilimumab). Cohort B will enroll NSCLC patients whose tumors have exon 19 deletion or exon 21 L858R mutation and will receive VT3989 in combination with targeted therapy (Osimertinib).

Connect with a study center

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Peter MacCullum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Monash Health

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Active - Recruiting

  • Peter MacCullum Cancer Centre

    Melbourne 2158177, Victoria 2145234 3000
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Active - Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California 94158
    United States

    Site Not Available

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco 5391959, California 5332921 94158
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center-

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, PC

    Arlington, Virginia 22201
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Arlington 4744709, Virginia 6254928 22201
    United States

    Active - Recruiting

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