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New treatment option for Recurrent Meningioma
Official title RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma
ClinicalTrials.gov ID: NCT07150806
What this study is testing
What is Actinium Ac 225 DOTATATE RYZ101?
Actinium Ac 225 DOTATATE RYZ101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent meningioma.
Also referred to as 225Ac-DOTA-TATE RYZ101, 225Ac-Oxodotreotide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Progressive residual tumor after maximal safe resection, located at or near critical organs at-risk and considered to be high-risk for radiation...
You likely can't join if
- 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...
- Prior radiopharmaceutical therapies (RPT), including radioembolization
- Prior solid organ or bone marrow transplantation
- Any toxicities from prior treatments that have not recovered to CTCAE grade ≤1, except for alopecia
See the full eligibility criteria
Who can 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 (bidirectional area) on imaging by 25% or more between scans separated by no...
- 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...
- For Grade II or III meningioma, people must have either:
- Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bi-directional area) on imaging by 25% or more between scans separated by no...
- 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 with SUV ratios adjusted to the liver uptake (Krenning score ≥ 2)
- 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 ≤ 3 measurable intracranial lesions on the most recent post-contrast MRI
- 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 unless there is...
- 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...
- 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...
- 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 ≤...
- Sufficient renal function, as evidenced by creatinine clearance (CrCl) ≥ 60 mL/min 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...
- 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...
- Sexually active male people 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 people 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...
- 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.
What rules you out
- 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 radiopharmaceutical therapies (RPT), including radioembolization
- Prior solid organ or bone marrow transplantation
- Any toxicities from prior treatments that have not recovered to CTCAE grade ≤1, except for alopecia
- 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...
- Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HgB A1c) \> 8% in patients with known diagnosis of diabetes mellitus)
- Liver cirrhosis
- Pregnancy or lactation
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.