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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

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Health
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
Peter MacCullum Cancer Centre
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Linear Clinical Research
Coordinator of this site? Confirm its status
NedlandsAustraliaRecruiting
Virginia Cancer Specialists, PC
Coordinator of this site? Confirm its status
ArlingtonUnited StatesRecruiting
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of Chicago Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
M Health Fairview University of Minnesota Medical Center
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
NEXT Oncology
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
UCSF Helen Diller Family Comprehensive Cancer Center
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.