NCT07150806

RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma

Progressive/Recurrent Intracranial Meningioma Treated With SSTR-Targeted Alpha Emitter RYZ101 (PRIMe-STAR)

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Joshua Palmer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II tests the safety, side effects, best dose and how well giving RYZ101 works for the treatment of patients with intracranial meningioma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). RYZ101 is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving RYZ101 may be safe, tolerable and/or effective in treating patients with progressive or recurrent intracranial meningioma.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the efficacy of 225Ac-DOTATATE (RYZ101) therapy in the treatment of patients with progressive or recurrent grade 1-3 intracranial meningioma as measured by the progression free survival at 6 months. SECONDARY OBJECTIVES: I. To evaluate the objective response rate (ORR) by standard of care brain magnetic resonance imaging (MRI) at 6 months and gallium Ga 68-DOTATATE (68Ga-DOTATATE) positron emission tomography (PET) imaging at 1 year. II. To determine the overall survival (by grade cohort) in patients with progressive / recurrent meningioma during or after treatment with RYZ101. III. To determine the progression-free survival (by grade cohort) in patients with progressive / recurrent meningioma during or after treatment with RYZ101. IV. To determine the toxicity rate in patients with progressive / recurrent meningioma during or after treatment with RYZ101. V. To perform semiquantitative analysis of PET standardized uptake value (SUV) uptake and compare to the background for treatment response assessment and as a potential biomarker of response and prognosis. OUTLINE: Patients receive RYZ101 intravenously (IV) and amino acids, with L-arginine and L-lysine, IV on day 1 of each cycle. Cycles repeat every 8 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients receive Ga 68-DOTATATE IV and undergo PET scan or somatostatin receptor (SSTR) PET scan, computed tomography (CT) scan, MRI and undergo blood and urine sample collection and may undergo echocardiography or multigated acquisition (MUGA) scan throughout the study. After completion of study treatment, patients are followed up every 3 months for 1 year.

Conditions

• Recurrent Meningioma

Interventions

Type	Name	Description
DRUG	Actinium Ac 225 DOTATATE RYZ101	Given IV
PROCEDURE	Biospecimen Collection	Undergo blood and urine sample collection
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Echocardiography Test	Undergo echocardiography
RADIATION	Gallium Ga 68-DOTATATE	Given IV
DRUG	L-lysine/L-arginine-containing Amino Acid	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA scan
PROCEDURE	Positron Emission Tomography	Undergo PET scan
PROCEDURE	Somatostatin Receptor Positron Emission Tomography	Undergo SSTR PET scan

Timeline

• Start date: 2025-11-12
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-09-02
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study