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RECRUITING
NCT07150806
PHASE1/PHASE2

RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma

Sponsor: Joshua Palmer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-11-12

Completion Date

2026-12-31

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

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

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States