Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult, Mesothelioma, NSCLC

In brief

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.

Key facts

Study ID

NCT04665206

Run by

Vivace Therapeutics, Inc

People needed

434

Starts

2021-03-24

Expected to finish

2030-03-02

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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