🔎 Trials Near Me

Home › Mesothelioma › NCT04665206

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

RecruitingPhase 1/2

Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients With Locally Advanced or Metastatic Solid Tumors

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Vivace Therapeutics, Inc · Participants: 434 · Started: Mar 24, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04665206

Locations in the U.S.

CaliforniaUCSF Helen Diller Family Comprehensive Cancer Center, San Francisco
IllinoisUniversity of Chicago Medical Center, Chicago
MassachusettsDana-Farber Cancer Institute, Boston
Massachusetts General Hospital, Boston
MinnesotaM Health Fairview University of Minnesota Medical Center, Minneapolis
New YorkMemorial Sloan Kettering Cancer Center, New York
TexasMD Anderson Cancer Center, Houston
NEXT Oncology, San Antonio
VirginiaVirginia Cancer Specialists, PC, Arlington

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.