Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - tumors that can be measured on scans 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. - your organs (liver, kidneys, etc.) are working well enough based on blood testss, including the liver, kidneys, and hematopoietic system. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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