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Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 Gene Mutations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04665206
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Vivace Therapeutics, Inc

Study Description
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Brief Summary:
This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered in patients with mesothelioma and/or metastatic solid tumors that are resistant or refractory to standard therapy or for which no effective standard therapy is available.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Mesothelioma Drug: VT3989 Phase 1

Detailed Description:

Dose Escalation will employ a traditional 3 + 3 design to assess safety of VT3989 in patients with refractory metastatic solid tumors or mesothelioma until until the MTD or recommended phase 2 dose(s) and schedule(s) are determined. The recommended phase 2 dose(s) and schedule(s) may be less than the MTD depending on the type and severity of AEs that occur during and after the first cycle.

Dose Expansion patients will be enrolled into up to 4 cohorts: Cohorts 1 and 2 will both enroll mesothelioma patients with or without an NF2 mutation that have progressed following standard therapy. The cohorts will differ by either the dose and/or schedule of VT3989, as recommended by the SRC. If a 3rd expansion cohort for mesothelioma patients is enrolled, it will employ a different regimen than the initial 2 expansion cohorts. If an NF2m solid tumor cohort is evaluated, it will use one of the regimens evaluated in the mesothelioma expansion cohorts.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Part 1 dose escalation: 3 + 3 design Part 2 dose expansion: up to 4 cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Multi-Center, Open-Label, Study to Evaluate the Safety, Tolerability, and PK of VT3989 in Patients With Refractory Locally Advanced or Metastatic Solid Tumors Enriched for Tumors Harboring Mutations of the NF2 Gene
Actual Study Start Date : March 24, 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: VT3989 Dose Escalation
VT3989 dosed orally in 21 or 28 day cycles. Patients will be enrolled into escalating dose levels during the Dose Escalation Phase
 Drug: VT3989
25 or 100 mg capsules for oral administration.
Experimental: Dose Expansion
VT3989 dosed in 21 or 28 day cycles in patients with refractory metastatic solid tumors or mesothelioma, with or without NF2 mutant tumors.
 Drug: VT3989
25 or 100 mg capsules for oral administration.


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of Dose Limiting Toxicity [ Time Frame: over the first 21 days of dosing ]
    Incidence of Adverse and Serious Adverse Events

  2. Occurrence of General Toxicity [ Time Frame: through study completion, an average of 30 months ]
    Incidence of Adverse and Serious Adverse Events, Discontinuations due to Adverse Events and general safety Evaluations


Secondary Outcome Measures :
  1. Tumor Response [ Time Frame: through study completion, an average of 30 months ]
    Determined by RECIST v1.1 or modified RECIST v1.1

  2. Pharmacokinetic Evaluation - Cmax [ Time Frame: over first 21 days of dosing ]
    Peak plasma concentration of VT3989

  3. Pharmacokinetic Evaluation - Tmax [ Time Frame: over first 21 days of dosing ]
    Time to reach peak plasma concentration of VT3989

  4. Pharmacokinetic Evaluation - Half-life [ Time Frame: over first 21 days of dosing ]
    Time required for the plasma concentration of VT3989 to reduce by half after reaching peak


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Part 1: pathologically diagnosed metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy;
  • Part 2: In mesothelioma cohorts, pathologically diagnosed advanced malignant mesothelioma with or without NF2 mutations, that has progressed on or after all approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy. In the solid tumor cohort, pathologically diagnosed solid tumor with documented NF2 mutations.
  • Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solid tumors (solid tumor expansion cohort) or modified RECIST v1.1 for malignant pleural mesothelioma.
  • ECOG: 0-1

Exclusion Criteria:

  • Active brain metastases
  • History of leptomeningeal metastases
  • Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • HIV positive or active Hepatitis B or Hepatitis C
  • Clinically significant cardiovascular disease
  • Additional active malignancy that may confound the assessment of the study endpoints
  • Women who are pregnant or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665206


Contacts
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Contact: Heather Fritz 650-627-7437 hfritz@inclin.com
Contact: Jill Abbey 925-286-0832 jabbey@vivacetherapeutics.com

Locations
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United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Australia, Victoria
Monash Health Recruiting
Clayton, Victoria, Australia, 3168
Peter MacCullum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Vivace Therapeutics, Inc
More Information
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Responsible Party: Vivace Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT04665206    
Other Study ID Numbers: VT3989-001
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mesothelioma
Neoplasms
Adenoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial