NCT04665206RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 434 (estimated)
- First submitted
- 5 Dec 2020
- Start date
- 24 Mar 2021
- Primary completion date
- 2 Nov 2029
- Lead sponsor
- Vivace Therapeutics, Inc
- Diseases
- Mesothelioma
- NCT number
- NCT04665206
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 434
- From 24 Mar 2021 to the primary completion date, 2 Nov 2029
- 12 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents.
- Prior treatment with TEAD inhibitor.
Other illness
- 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
Lab values
- Corrected QT (QTcF) interval \> 470 msec (using Fridericia's correction formula).
Other
- Active brain metastases or primary CNS (central nervous system) tumors.
- Women who are pregnant or breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Peter MacCullum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Virginia Cancer Specialists, PC Coordinator of this site? Confirm its status | Arlington | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| M Health Fairview University of Minnesota Medical Center Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| UCSF Helen Diller Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.