RYZ101 for Meningioma

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Joshua Palmer

Must not be taking: Radiopharmaceuticals, Antihypertensives, Antidiabetics, others

Disqualifiers: ECOG > 2, Cardiovascular, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 32 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Joshua D Palmer, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with intracranial meningioma that's growing, spreading, or has returned after improvement. Participants must have measurable disease and be able to undergo various imaging tests like PET scans and MRIs.

Inclusion Criteria

Positive 68Ga-DOTATATE uptake on PET/CT at baseline

Presence of measurable disease defined as at least one lesion measuring ≥ 5 mm in at least one dimension by contrast-enhanced MRI

Patients must be willing and able to undergo regular MRI scans of the brain

Exclusion Criteria

History of hypersensitivity or allergy to specific agents

Pregnancy, lactation

Unable to understand or unwilling to sign an Institutional review board approved written informed consent document

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RYZ101 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.

32 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months for 1 year.

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RYZ101

Trial Overview The trial is testing RYZ101, a radioactive drug targeting somatostatin receptors on tumor cells. It includes phase I/II to determine safety, side effects, optimal dosage, and effectiveness in treating progressive or recurrent meningioma.

How Is the Trial Designed?

Group I: Treatment (RYZ101) Experimental Treatment 10 Interventions

Patients receive RYZ101 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 gallium Ga 68-DOTATATE IV and undergo PET scan or SSTR PET scan, CT scan, MRI and undergo blood and urine sample collection and may undergo echocardiography or MUGA scan throughout the study.

Who Is Running the Clinical Trial?

Joshua Palmer

Lead Sponsor

Trials

1

Recruited

60+

RayzeBio, Inc.

Industry Sponsor

Trials

6

Recruited

540+