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Recurrent MeningiomaPhase 1/2NCT07150806

RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma

A Phase 1/2 study testing Actinium Ac 225 DOTATATE RYZ101, Biospecimen Collection and Computed Tomography in people with Recurrent Meningioma, run by Joshua Palmer at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Meningioma
What is being tested?
Actinium Ac 225 DOTATATE RYZ101, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
12 Nov 2025to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients of age > 18 years
  • Patients with 68Ga-DOTATATE positive recurrent or progressive meningiomas, any World Health Organization (WHO) grade, who have progressed after first line treatment.
  • For Grade I meningioma, patients must have either:
  • Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion on imaging by 25% or more between scans separated by no more than 12 months; or
  • Progressive residual tumor after maximal safe resection, located at or near critical organs at-risk and considered to be high-risk for radiation injury by the treating investigator. Prior external beam radiotherapy is not required for these subjects.
  • For Grade II or III meningioma, subjects must have either:
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  • Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion on imaging by 25% or more between scans separated by no more than 12 months or
  • Residual measurable disease after prior surgery without requirement of progression, or
  • Unsuitable for, or decline other standard of care treatment.
  • Positive 68Ga-DOTATATE uptake on PET/CT at baseline, defined as target lesion uptake higher than the background
  • Presence of measurable disease defined as at least one lesion measuring ≥ 5 mm in at least one dimension by contrast-enhanced MRI performed within 30 days prior to study registration
  • Multifocal disease allowed but limited to the physician discretion for safety (ie. large mass effect or damage to nearby critical organs with prior radiation treatment.)
  • There is no limit on the number of prior surgeries, radiation therapy, radiosurgery, systemically administered therapeutic agents or theranostic agents
  • For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval ≥ 24 weeks must have elapsed from completion from these therapies to registration
  • An interval of ≥ 28 days (or 5 half-lives, whichever is shorter) from prior cytotoxic chemotherapy (6 weeks from nitrosoureas), biologic agent, investigational agent or any other systemic agent prescribed for the purpose of treating meningioma
  • An interval of ≥ 28 days from craniotomy and ≥ 7 days from stereotactic biopsy
  • Patients must be willing and able to undergo regular MRI scans of the brain
  • Patients must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include alopecia, laboratory values listed per inclusion criteria, lymphopenia, sensory neuropathy ≤ grade 2, or other ≤ grade 2 not constituting a safety risk based on the investigator's judgment)
  • Any neurological symptoms must be stable for at least 28 days prior to enrollment and patients should not require escalating doses of steroids to control neurological symptoms (stable low dose maintenance steroids at ≤ 8 mg dexamethasone or equivalent are allowed)
  • Sufficient renal function, as evidenced by creatinine clearance (CrCl) ≥ 60 mL/min or eGFR ≥60 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
  • Hemoglobin concentration ≥ 5.0 mmol/L (≥ 8.0 g/dL)
  • Note: Colony-stimulating factors, platelet-production stimulators and/or transfusions within 4 weeks prior to screening and first dose of study treatment are not permitted to meet these criteria
  • Absolute neutrophil count (ANC) ≥ 1000 cells/µL (≥ 1000 cells/mm^3)
  • Note: Colony-stimulating factors, platelet-production stimulators and/or transfusions within 4 weeks prior to screening and first dose of study treatment are not permitted to meet these criteria.
  • Platelets > 100 × 10^9/L (100 × 10^3/mm^3)
  • Note: Colony-stimulating factors, platelet-production stimulators and/or transfusions within 4 weeks prior to screening and first dose of study treatment are not permitted to meet these criteria.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) (or ≤ 5 × ULN if presence of liver metastases)
  • Total bilirubin ≤ 3 × ULN
  • Serum albumin ≥ 3.0 g/dL
  • Adequate coagulation function, defined by international normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, unless subject is receiving anticoagulant therapy and PT or aPTT is within therapeutic range of intended use of anticoagulants
  • For women of childbearing potential (WOCBP):
  • Negative pregnancy test within 48 hours prior to the first dose of study treatment
  • Agreement to use barrier contraception and a second form of highly effective contraception while receiving study treatment and for 7 months following their last dose of study treatment. Alternatively, total abstinence is also considered a highly effective contraception method when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • A woman is considered to be of childbearing potential if she is postmenarche, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea [no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before first dose of study treatment)
  • Sexually active male subjects must use a condom during intercourse while receiving RYZ101 and for at least 120 days after the last dose of the study treatment and should not father a child during this period.
  • Male study subjects whose sexual partners are WOCBP must also agree to use a second form of highly effective contraception while receiving RYZ101 and for at least 4 months following their last dose. Alternatively, total abstinence is also considered a highly effective contraception method when this is in line with the preferred and usual lifestyle of the subject.
  • Vasectomized men are also required to use a condom during intercourse, including with a male partner, to prevent delivery of the drug via seminal fluid.
  • The subject, or their legally authorized representative, must provide informed consent

Who cannot join

  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Received radiation therapy to the brain in last 24 weeks
  • History of hypersensitivity or allergy to Actinium Ac-225 (225Ac), Gallium Ga 68 (68Ga), Copper Cu 64 (64Cu), octreotate, or any of the excipients of DOTATATE imaging agents
  • Prior alpha radiopharmaceutical therapies (RPT), including radioembolization
  • Prior solid organ or bone marrow transplantation
  • Significant cardiovascular disease, defined as:
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  • New York Heart Association (NYHA) Class ≥ II heart failure.
  • Known left ventricular ejection fraction (LVEF) < 50%.
  • History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the last 6 months.
  • QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 ms, demonstrated by the average value of 3 consecutive electrocardiograms (ECGs).
  • Resistant hypertension, defined as persistent uncontrolled blood pressure (BP) > 140/90 mmHg while on optimal doses of at least 3 antihypertensive medications with 1 being a diuretic. Patients with baseline hypertension may be eligible after initiation of antihypertensive therapy
  • Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HgB A1c) > 8% in patients with known diagnosis of diabetes mellitus)
  • Liver cirrhosis or liver transplantation
  • Pregnancy or lactation
  • Subject, or their legally authorized representative, unable to understand or unwilling to sign an Institutional review board approved written informed consent document
  • Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Central Nervous System Research Team contact

614-293-9974

_CNSCRCs_@osumc.edu

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    CNS Research Team, 614-293-9974, _CNSCRCs_@osumc.edu

    Joshua D. Palmer, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

  1. 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.

Being tested
Actinium Ac 225 DOTATATE RYZ101, Biospecimen Collection, Computed Tomography, Echocardiography Test, Gallium Ga 68-DOTATATE
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Actinium Ac 225 DOTATATE RYZ101Drug

    Also called 225Ac-DOTA-TATE RYZ101, 225Ac-Oxodotreotide, Actinium Ac 225-Dotatate RYZ101, ACTINIUM AC-225 DOTATATE

    Given IV

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and urine sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo echocardiography

  • Gallium Ga 68-DOTATATERadiation

    Also called (68)Ga-DOTA-TATE, 68Ga-DOTA-0-Tyr3-Octreotate, 68Ga-DOTATATE, Gallium Ga 68 Oxodotreotide

    Given IV

  • L-lysine/L-arginine-containing Amino AcidDrug

    Also called Amino Acid Renal Protectant Solution, Amino Acid Solution-containing L-lysine and L-arginine, Intravenous L-lysine/L-arginine-containing Amino Acid Solution, L-lysine/L-arginine AA Solution

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA scan

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • Somatostatin Receptor Positron Emission TomographyProcedure or surgery

    Also called SSTR-PET

    Undergo SSTR PET scan

Study groups in NCT07150806
Study groupRoleWhat they receive
Treatment (RYZ101)ExperimentalPatients 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.
Receives: Drug: Actinium Ac 225 DOTATATE RYZ101; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Radiation: Gallium Ga 68-DOTATATE; Drug: L-lysine/L-arginine-containing Amino Acid; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Procedure: Somatostatin Receptor Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    Defined as survival without progression of disease (progressive disease, based on Response Assessment in Neuro-Oncology Criteria [RANO] 2.0 criteria) or death. Kaplan-Meier analyses will be used to estimate PFS.

    Measured: At 6 months

Secondary outcomes (4)

  1. Objective response rate (ORR)

    Assessed by standard of care brain magnetic resonance imaging (MRI) at 6 months and gallium Ga 68-DOTATATE positron emission tomography (PET) at 1 year. ORR defined as the best response including complete response, partial response or stable disease per RANO 2.0 criteria.

    Measured: At 6 months and 1 year

  2. Overall survival (OS)

    Kaplan-Meier analyses will be used to estimate OS.

    Measured: From the date of trial enrolment to date of death, up to 2 years

  3. Incidence of adverse events

    The number and type of adverse events will be summarized, using the NCI's Common Toxicity Criteria for Adverse Events, version 5.0 (CTCAE V.5.0).

    Measured: Up to 2 years

  4. PET standardized uptake value uptake

    To compare to the background for treatment response assessment and as a potential biomarker of response and prognosis.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2025
  2. Study start12 Nov 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07150806
Sponsor's protocol ID
OSU-24368
Other IDs
NCI-2025-06045
Status last verified
Aug 2026
First submitted
27 Aug 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Actinium Ac 225 DOTATATE RYZ101, Biospecimen Collection and Computed Tomography in people with Recurrent Meningioma, run by Joshua Palmer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Central Nervous System Research Team (614-293-9974, _CNSCRCs_@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: At 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07150806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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