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

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vivace Therapeutics, Inc

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