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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
Vivace Therapeutics, Inc
This is a sequential assignment trial with two phases. Phase 1 focuses on Dose Escalation. During dose escalation, participants will receive VT3989 dosed orally once per day in 21 day cycles, at escalating dose levels, until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is determined.
Phase 2 focuses on Dose Expansion. During Dose Expansion, participants will be divided 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 tumour patients with mutations of NF2 that have progressed on or following standard therapy. Participants 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.