Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 or mNF2 Gene Mutations

Sponsor: Vivace Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04665206

Patient View

This open-label study evaluates VT3989's safety and activity in patients with refractory metastatic solid tumors or mesothelioma. Using a 3+3 dose escalation design, it determines the MTD, followed by dose expansion in specific cohorts. Eligible patients have progressed on standard therapies and must have measurable disease per RECIST criteria. VT3989 is administered orally in varying doses.

Patient Parameters

Program Overview

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 3- or 4-week cycles 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.

Description

Dose escalation will employ a traditional 3 + 3 design to assess safety of VT3989 in patients with refractory metastatic solid tumors or mesothelioma. The 3 + 3 design will be implemented until the MTD or recommended phase 2 dose(s) and schedule(s) are determined. The MTD is defined as the highest dose level at which < 33% of patients experience a dose limiting toxicity (DLT) during the first cycle of the study (Cycle 1).

Dose Expansion will further evaluate the safety and assess preliminary antitumor activity at the recommended phase 2 dose(s) and schedule(s) with up to 6 cohorts using optimal 2-stage Simon designs. Expansion cohorts 1 and 2 will enroll patients with mesothelioma of any site origin with or without NF2 mutations. Expansion cohort 3 will enroll non-pleural mesothelioma patients. Expansion cohort 4 will enroll solid tumor patients with clearly inactivating NF2 mutations/alterations or YAP/TAZ gene rearrangements.

Eligibility 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 with clearly inactivating NF2 mutations/alterations or YAP/TAZ gene rearrangements, which have progressed on or after approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy.
  • 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 or primary CNS (central nervous system) tumors.
  • 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
  • Prior treatment with TEAD inhibitor

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