Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 Gene Mutations
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Mesothelioma
- Solid Tumor, Adult
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Part 1 dose escalation: 3 + 3 design Part 2 dose expansion: 2 parallel cohortsMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04665206
- Collaborators
- Not Provided
- Investigators
- Not Provided