RECRUITING

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

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Conditions

Solid Tumor, AdultMesotheliomaNSCLC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-24
Study Completion:2027-06-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04665206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Part 1: Patients with pathologically diagnosed metastatic solid tumor or mesothelioma who have progressed on or after all approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy.
  2. * Part 2 Expansion Cohorts 1 and 2: In mesothelioma cohorts, patients with pathologically diagnosed advanced malignant mesothelioma with or without NF2 mutations, who have progressed on or after all approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy.
  3. * Part 2 Expansion Cohort 3: Only non-pleural mesothelioma patients with epithelioid histology, who have relapsed from or are refractory to prior platinum-based chemotherapy and immunotherapy.
  4. * Part 2 Expansion Cohort 4: in the solid tumor cohort, patients with pathologically diagnosed metastatic or locally advanced solid tumor with clearly inactivating NF2 mutations/alterations or YAP/TAZ gene rearrangements, who have progressed on or after approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy.
  5. * Part 2 Expansion Cohort 5: Patients with pathologically diagnosed advanced malignant pleural mesothelioma with epithelioid histology, who have progressed on or after licensed immunotherapy, chemotherapy or combined chemoimmunotherapy, except if the patient refuses or is not a candidate for such therapy.
  6. * 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.
  7. * 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.
  8. * Part 1: Evaluable or measurable disease per RECIST v1.1 or mRECIST
  9. * Part 2 and 3: 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.
  10. * ECOG: 0-1.
  11. * Adequate organ functions, including the liver, kidneys, and hematopoietic system.
  1. * Active brain metastases or primary CNS (central nervous system) tumors.
  2. * History of leptomeningeal metastases
  3. * Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  4. * Known HIV positive or active Hepatitis B or Hepatitis C
  5. * Clinically significant cardiovascular disease
  6. * 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).
  7. * Additional active malignancy that may confound the assessment of the study endpoints
  8. * Women who are pregnant or breastfeeding
  9. * Prior treatment with TEAD inhibitor, except for EHE patients.

Contacts and Locations

Study Contact

Heather Fritz
CONTACT
650-627-7437
hfritz@inclin.com
Neelesh Sharma, MD
CONTACT
732-476-4978
nsharma@vivacetherapeutics.com

Principal Investigator

Neelesh Sharma, MD
STUDY_DIRECTOR
Vivace Therapeutics

Study Locations (Sites)

University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
Virginia Cancer Specialists, PC
Arlington, Virginia, 22201
United States

Collaborators and Investigators

Sponsor: Vivace Therapeutics, Inc

  • Neelesh Sharma, MD, STUDY_DIRECTOR, Vivace Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-24
Study Completion Date2027-06-02

Study Record Updates

Study Start Date2021-03-24
Study Completion Date2027-06-02

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor, Adult
  • Mesothelioma
  • NSCLC