Tests VT3989 alone or with other drugs in solid tumors
Tests VT3989, alone or combined, in adults with mesothelioma or advanced solid tumors.
Plain-language title generated from the registry record
Registry title: Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors
Key facts
- Where
- Arlington, Boston, Chicago, Houston, Minneapolis, New York, San Antonio, and San Francisco, United StatesSee the 9 sites
- Phase
- Phase 1/2
Where in United States
- Virginia Cancer Specialists, PCArlington, United StatesTaking people
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- University of Chicago Medical CenterChicago, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- M Health Fairview University of Minnesota Medical CenterMinneapolis, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- NEXT OncologySan Antonio, United StatesTaking people
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vivace Therapeutics, Inc
- Trial code
- NCT04665206
- Record updated
- 2 April 2026
- Original description
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.Read full original descriptionShow less
Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients With Locally Advanced or Metastatic Solid Tumors
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.
Inclusion: 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: Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents; Prior treatment with TEAD inhibitor; 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; Additional active malignancy that may confound the assessment of the study endpoints; Corrected QT (QTcF) interval > 470 msec (using Fridericia's correction formula); Active brain metastases or primary CNS (central nervous system) tumors; Women who are pregnant or breastfeeding.