RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma

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.

Conditions

• Recurrent Meningioma

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

Sponsors & Collaborators

• RayzeBio, Inc.

  collaborator INDUSTRY

• Joshua Palmer

  lead OTHER

Principal Investigators

• Joshua D Palmer, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-12

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations