Evaluating VT3989 for 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
This study is testing a new drug called VT3989 to see if it can help people with hard-to-treat metastatic solid tumors, including mesothelioma, feel better and fight their cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 434 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vivace Therapeutics, Inc Industry-sponsored |
| Drugs / interventions | Osimertinib, chemotherapy, nivolumab, ipilimumab, immunotherapy |
| Locations | 12 sites (San Francisco, California and 11 other locations) |
| Trial ID | NCT04665206 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with metastatic solid tumors or mesothelioma that have progressed after standard therapies.
Not a fit: Patients with tumors that are not metastatic or those who have not exhausted standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have limited or no effective therapies available.
How similar studies have performed: Other studies have shown promise with similar approaches, particularly in targeting resistant solid tumors, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California and 11 other locations
- 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)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- Virginia Cancer Specialists, PC — Arlington, Virginia, United States (Recruiting)
- Monash Health — Clayton, Victoria, Australia (Recruiting)
- Peter MacCullum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
- Linear Clinical Research — Nedlands, Western Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Heather Fritz
- Email: hfritz@inclin.com
- Phone: 650-627-7437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.