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

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ClinicalTrials.gov Identifier: NCT04665206
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : November 2, 2021
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 once-daily in patients with advanced pleural malignant 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 advanced malignant pleural mesothelioma until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is determined. The RP2D may be less than the MTD depending on the type and severity of AEs that occur during and after the first cycle.

In Dose Expansion, patients will be enrolled into 2 cohorts: Cohort 1 - malignant pleural mesothelioma patients with mutations of NF2 that have progressed on or following standard therapy; and Cohort 2 - solid tumor patients with mutations of NF2 that have progressed on or following standard therapy. Patients will be treated at the MTD or RP2D identified in Part 1, to provide further characterization of the safety, tolerability, efficacy, and biological activity of VT3989.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Part 1 dose escalation: 3 + 3 design Part 2 dose expansion: 2 parallel 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 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 day cycles in patients with refractory metastatic solid tumors, or advanced pleural malignant mesothelioma, with 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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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 advanced malignant pleural mesothelioma that has progressed on or after standard of care therapy with evaluable or measurable disease per RECIST v1.1
  • Part 2: pathologically diagnosed advanced malignant pleural mesothelioma with NF2 mutations (Cohort 1) or metastatic solid tumors with NF2 mutation (Cohort 2), for which there is no further standard of care therapy available with measurable disease per RECIST v1.1 for solid tumors 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: November 2, 2021
Last Verified: October 2021
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