Recruitment

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