Evaluating VT3989 for patients with metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, dose escalation and expansion study aims to assess the safety, tolerability, pharmacokinetics, and biological activity of VT3989 in patients with mesothelioma and metastatic solid tumors that are resistant or refractory to standard therapies. The study will utilize a traditional 3 + 3 design to determine the maximum tolerated dose (MTD) and will include multiple cohorts for dose expansion to evaluate preliminary antitumor activity. Patients will receive VT3989 alone or in combination with immunotherapy or targeted therapy based on their specific tumor characteristics.

Why it matters

Who can join: the full rules

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.

Where it's running

• UCSF Helen Diller Family Comprehensive Cancer Center
  San Francisco, California, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• M Health Fairview University of Minnesota Medical Center
  Minneapolis, Minnesota, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Heather Fritz
• Email: hfritz@inclin.com
• Phone: 650-627-7437

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.