RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma
{ "RYZ101 for Progressive or Recurrent Intracranial Meningioma", "This study is testing a drug called RYZ101 for people with meningioma (a type of brain tumor) that is growing or has come back after previous treatment. RYZ101 is a radioactive drug given through an IV. It works by targeting a specific protein (somatostatin receptor) found on some tumor cells, delivering radiation that may help kill them. To join, you must be over 18 and have meningioma that has progressed after initial treatment, and your tumor must show up on a special scan using Gallium Ga 68-DOTATATE. The main goal is to see how many people's tumors stop growing for at least 6 months after treatment. The study is currently unclear on its recruitment status and plans to enroll 30 participants.", "design": "This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.", "commitments": "You would receive RYZ101 and amino acids through an IV every 8 weeks for up to 4 cycles. You would also have blood and urine tests, CT scans, echocardiograms, and Gallium Ga 68-DOTATATE scans.", "compensation": "Not stated in the trial record.", "follow_up": "The study measures progression-free survival at 6 months and objective response rate at 6 months and 1 year, suggesting follow-up for at least a year after treatment.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07150806
RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma
Recruiting
PHASE1Ages 18+InterventionalTreatmentJoshua PalmerInvestigator-initiated
~30 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Actinium Ac 225 DOTATATE RYZ101Biospecimen CollectionComputed TomographyEchocardiography TestGallium Ga 68-DOTATATEL-lysine/L-arginine-containing Amino Acid
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over At 6 months
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Joshua D Palmer, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
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
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.
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
Exclusion
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:
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
What this trial measures
- Progression free survival (PFS)At 6 months
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.