Actively Recruiting
Progressive/Recurrent Intracranial Meningioma Treated With SSTR-Targeted Alpha Emitter RYZ101 (PRIMe-STAR)
Led by Joshua Palmer · Updated on 2026-05-22
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Joshua Palmer
Lead Sponsor
R
RayzeBio, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, best dose, and effectiveness of RYZ101, a radioactive drug, for treating patients with intracranial meningioma that is growing, spreading, worsening, or has returned after improvement. This phase I/II trial focuses on meningiomas that are progressive or recurrent and uses RYZ101, which targets a protein called somatostatin receptor found on some neuroendocrine tumor cells. The drug delivers radiation directly to these cells to potentially kill them. Participants receive RYZ101 intravenously along with amino acids L-arginine and L-lysine on the first day of each treatment cycle. These cycles repeat every 8 weeks for up to 4 cycles unless the disease progresses or unacceptable side effects occur. Throughout the study, patients undergo PET scans using gallium Ga 68-DOTATATE or somatostatin receptor PET scans, CT scans, MRI, and may have echocardiography or MUGA scans. Blood and urine samples are also collected regularly. During the study, researchers monitor patients with imaging and laboratory tests to track tumor response and side effects. They assess progression-free survival at 6 months as the main outcome and also review overall survival, objective response rates, and PET scan uptake values. After completing treatment, patients are followed up every 3 months for one year to continue monitoring their condition and safety. Total participation may last up to two years including follow-up.
CONDITIONS
Brief Title
RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged over 18 years
- Patients with recurrent or progressive meningiomas positive for 68Ga-DOTATATE, any WHO grade, who have progressed after first line treatment
- For Grade I meningioma: progressive disease after surgery and radiotherapy or progressive residual tumor near critical organs
- For Grade II or III meningioma: progressive disease after surgery and radiotherapy, residual measurable disease, or unsuitable for other treatments
- Positive PET uptake with Krenning score of 2 or higher
- At least one measurable lesion of 5 mm or larger on MRI within 30 days before registration
- Up to 3 measurable intracranial lesions allowed
- No limit on prior surgeries, radiation, or therapies
- At least 24 weeks since radiation therapies unless confirmed recurrent tumor
- At least 28 days since chemotherapy or other systemic agents
- At least 28 days since craniotomy and 7 days since stereotactic biopsy
- Willing and able to undergo regular brain MRI scans
- Recovered to CTCAE grade 1 or baseline from prior treatment side effects
- Stable neurological symptoms for at least 28 days and stable low dose steroids allowed
- Adequate kidney function with creatinine clearance at least 60 mL/min
- Hemoglobin at least 8.0 g/dL without recent stimulators or transfusions
- Absolute neutrophil count at least 1000 cells/μL without recent stimulators or transfusions
- Platelets above 100 x 10^9/L without recent stimulators or transfusions
- Liver enzymes and bilirubin within specified limits
- Serum albumin at least 3.0 g/dL
- Adequate coagulation function or therapeutic anticoagulation
- For women of childbearing potential: negative pregnancy test and agreement to use effective contraception
- Sexually active men must use condoms and another contraception method during and after treatment
You will not qualify if you...
- ECOG performance status greater than 2
- Received brain radiation therapy within last 24 weeks
- Allergy to Actinium Ac-225, Gallium Ga 68, Copper Cu 64, octreotate, or DOTATATE agents
- Previous radiopharmaceutical therapies including radioembolization
- Prior organ or bone marrow transplant
- Unresolved toxicities from prior treatments above CTCAE grade 1 except alopecia
- Significant heart disease including heart failure class II or higher, recent heart attack, low ejection fraction, prolonged QT interval, or resistant hypertension
- Uncontrolled diabetes with hemoglobin A1C above 8%
- Liver cirrhosis
- Pregnancy or breastfeeding
- Unable or unwilling to consent
- Current serious physical or psychiatric conditions interfering with study objectives and assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 32 weeks (4 cycles of 8 weeks each)
Participants receive RYZ101 and amino acids intravenously on day 1 of each cycle, repeated every 8 weeks for up to 4 cycles if there is no disease progression or unacceptable toxicity. During treatment, participants undergo PET or SSTR PET scans, CT scans, MRI, blood and urine sample collection, and may have echocardiography or MUGA scans.
1 visit per cycle every 8 weeks, plus additional imaging and sample collection visits throughout treatment
Duration - 1 year
After completing treatment, participants are followed up every 3 months for 1 year to monitor their health and disease status.
Quarterly visits every 3 months for 1 year
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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