Clinical Trials /

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

NCT04665206

Description:

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.

Related Conditions:
  • Malignant Pleural Mesothelioma
  • Malignant Solid Tumor
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 Gene Mutations
  • 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

Clinical Trial IDs

  • ORG STUDY ID: VT3989-001
  • NCT ID: NCT04665206

Conditions

  • Solid Tumor, Adult
  • Mesothelioma

Interventions

DrugSynonymsArms
VT3989Dose Expansion

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
VT3989 Dose EscalationExperimentalVT3989 dosed orally once per day in 21 day cycles. Patients will be enrolled into escalating dose levels during the Dose Escalation Phase
  • VT3989
Dose ExpansionExperimentalVT3989 dosed once per day in 21 day cycles in patients with refractory metastatic solid tumors, or advanced pleural malignant mesothelioma, with NF2 mutant tumors.
  • VT3989

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Occurrence of Dose Limiting Toxicity
Time Frame:over the first 21 days of dosing
Safety Issue:
Description:Incidence of Adverse and Serious Adverse Events

Secondary Outcome Measures

Measure:Tumor Response
Time Frame:through study completion, an average of 30 months
Safety Issue:
Description:Determined by RECIST v1.1 or modified RECIST v1.1
Measure:Pharmacokinetic Evaluation - Cmax
Time Frame:over first 21 days of dosing
Safety Issue:
Description:Peak plasma concentration of VT3989
Measure:Pharmacokinetic Evaluation - Tmax
Time Frame:over first 21 days of dosing
Safety Issue:
Description:Time to reach peak plasma concentration of VT3989
Measure:Pharmacokinetic Evaluation - Half-life
Time Frame:over first 21 days of dosing
Safety Issue:
Description:Time required for the plasma concentration of VT3989 to reduce by half after reaching peak

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Vivace Therapeutics, Inc

Last Updated

December 11, 2020