RYZ101 Treatment for Progressive or Recurrent Intracranial Meningioma Using Targeted Alpha Therapy Phase 12 Study Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety, side effects, best dose, and effectiveness of RYZ101, a radioactive drug, for treating patients with intracranial meningioma that is growing, spreading, worsening, or has returned after improvement. This phase III trial focuses on meningiomas that are progressive or recurrent and uses RYZ101, which targets a protein called somatostatin receptor found on some neuroendocrine tumor cells. The drug delivers radiation directly to these cells to potentially kill them. Participants receive RYZ101 intravenously along with amino acids L-arginine and L-lysine on the first day of each treatment cycle. These cycles repeat every 8 weeks for up to 4 cycles unless the disease progresses or unacceptable side effects occur. Throughout the study, patients undergo PET scans using gallium Ga 68-DOTATATE or somatostatin receptor PET scans, CT scans, MRI, and may have echocardiography or MUGA scans. Blood and urine samples are also collected regularly. During the study, researchers monitor patients with imaging and laboratory tests to track tumor response and side effects. They assess progression-free survival at 6 months as the main outcome and also review overall survival, objective response rates, and PET scan uptake values. After completing treatment, patients are followed up every 3 months for one year to continue monitoring their condition and safety. Total participation may last up to two years including follow-up.

RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma