RecruitingPhase 1Phase 2NCT07150806

RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma

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


Sponsor

Joshua Palmer

Enrollment

30 participants

Start Date

Nov 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Actinium Ac 225 DOTATATE RYZ101, a procedure called Biospecimen Collection, and others for people with recurrent meningioma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGActinium Ac 225 DOTATATE RYZ101

Given IV

PROCEDUREBiospecimen Collection

Undergo blood and urine sample collection

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREEchocardiography Test

Undergo echocardiography

RADIATIONGallium Ga 68-DOTATATE

Given IV

DRUGL-lysine/L-arginine-containing Amino Acid

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREMultigated Acquisition Scan

Undergo MUGA scan

PROCEDUREPositron Emission Tomography

Undergo PET scan

PROCEDURESomatostatin Receptor Positron Emission Tomography

Undergo SSTR PET scan


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT07150806


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