Status:
RECRUITING
Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors
Lead Sponsor:
Vivace Therapeutics, Inc
Conditions:
Solid Tumor, Adult
Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 wit...
Detailed Description
Dose escalation (Part 1) will employ a traditional 3 + 3 design to assess safety of VT3989 in patients with metastatic solid tumors or mesothelioma. The 3 + 3 design will be implemented until the MTD ...
Eligibility Criteria
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.
- 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
- 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
- Corrected QT (QTcF) interval \> 470 msec (using Fridericia's correction formula); except for Part 2 Expansion Cohort 3, the QTcF interval criteria is \> 450 msec).
- Additional active malignancy that may confound the assessment of the study endpoints
- Women who are pregnant or breastfeeding
- Prior treatment with TEAD inhibitor, except for EHE patients.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 2 2027
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT04665206
Start Date
March 24 2021
End Date
June 2 2027
Last Update
October 28 2025
Active Locations (12)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215