Phase 2 Study Evaluating Zanzalintinib for Adults With Recurrent or Progressive Meningioma After Standard Treatments

What this Trial Is About

Researchers are evaluating the efficacy and safety of zanzalintinib in adults with recurrent or progressive meningioma that has not responded to standard treatments. This phase 2 study focuses on participants who have experienced tumor growth or new lesions despite prior therapies such as surgery and radiation. The study aims to better understand the treatment effects of zanzalintinib in these patients. Participants will receive zanzalintinib once daily as the investigational drug. The study includes only one treatment group where all participants receive this medication. Treatment continues while monitoring tumor response and progression according to established neuro-oncology criteria. The study period includes up to approximately 12 months of evaluation of tumor response, with secondary outcomes assessed up to around 48 months. During the study, participants will undergo assessments including scans to measure tumor size, evaluations of neurological function using the NANO scale, and quality of life questionnaires EQ-5D-5L. Safety is monitored by tracking treatment-related adverse events. The main outcome is the objective response rate assessed by blinded independent review. Participants may be followed for up to four years to evaluate progression-free and overall survival. The total study duration extends until September 2029.

A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma