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)
Occurrence of Dose Limiting Toxicity — over the first 21 days of dosing Incidence of Adverse and Serious Adverse Events
Occurrence of General Toxicity — through study completion, an average of 30 months Incidence of Adverse and Serious Adverse Events, Discontinuations due to Adverse Events and general safety evaluations
Trial sites (12)
Facility
City
Region
Status
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.