Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors
NCT ID: NCT04665206
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
336 participants
INTERVENTIONAL
2021-03-24
2027-06-02
Brief Summary
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Detailed Description
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Dose Expansion (Part 2) will further evaluate the safety and assess preliminary antitumor activity at the recommended phase 2 dose(s) and schedule(s) with up to 6 cohorts. Expansion cohorts 1 and 2 will enroll patients with mesothelioma of any site origin with or without NF2 mutations. Expansion cohort 3 will enroll non-pleural mesothelioma patients. Expansion cohort 4 will enroll solid tumor patients with clearly inactivating NF2 mutations/alterations or YAP/TAZ gene rearrangements. Cohort 5 will enroll pleural mesothelioma patients.
Combination part (Part 3) includes two cohorts. Cohort A will enroll mesothelioma patients who will receive VT3989 in combination with immunotherapy (nivolumab plus ipilimumab). Cohort B will enroll NSCLC patients whose tumors have exon 19 deletion or exon 21 L858R mutation and will receive VT3989 in combination with targeted therapy (Osimertinib).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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VT3989 Dose Escalation [Not Recruiting]
VT3989 dosed orally in 21 or 28 day cycles. Patients will be enrolled into escalating dose levels during the Dose Escalation Phase
VT3989
25, 50, 100, 150 or 200 mg capsules for oral administration.
Dose Expansion [Not Recruiting]
VT3989 dosed in 21 or 28 day cycles in patients with refractory metastatic solid tumors or mesothelioma.
VT3989
25, 50, 100, 150 or 200 mg capsules for oral administration.
Combination [Recruiting]
VT3989 dosed in 28 day cycles in patients with metastatic solid tumors or mesothelioma, in combination with immunotherapy (nivolumab/ipilimumab) or targeted therapy (osimertinib)
VT3989
25, 50, 100, 150 or 200 mg capsules for oral administration.
Nivolumab & Ipilimumab
Nivolumab infusion - 360 mg every 3 weeks, 30-minute intravenous infusion
Ipilimumab infusion - 1 mg/kg every 6 weeks, 30-minute intravenous infusion
Osimertinib
40 or 80 mg tablets for oral administration
Interventions
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VT3989
25, 50, 100, 150 or 200 mg capsules for oral administration.
Nivolumab & Ipilimumab
Nivolumab infusion - 360 mg every 3 weeks, 30-minute intravenous infusion
Ipilimumab infusion - 1 mg/kg every 6 weeks, 30-minute intravenous infusion
Osimertinib
40 or 80 mg tablets for oral administration
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Vivace Therapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Neelesh Sharma, MD
Role: STUDY_DIRECTOR
Vivace Therapeutics
Locations
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Virginia Cancer Specialists, PC
Arlington, Virginia, United States
Monash Health
Clayton, Victoria, Australia
Peter MacCullum Cancer Centre
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Yap TA, Kwiatkowski DJ, Dagogo-Jack I, Offin M, Zauderer MG, Kratzke R, Desai J, Body A, Millward M, Tolcher AW, Raghav KPS, Thurston A, Post L, Dorr FA, Tang TT, Li Y, Sharma N, Kindler HL. YAP/TEAD inhibitor VT3989 in solid tumors: a phase 1/2 trial. Nat Med. 2025 Oct 19. doi: 10.1038/s41591-025-04029-3. Online ahead of print.
Other Identifiers
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VT3989-001
Identifier Type: -
Identifier Source: org_study_id
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