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 trial examines the effectiveness of a new treatment, RYZ101, for individuals with meningioma, a type of brain tumor that has worsened or recurred after treatment. RYZ101 is a radioactive drug targeting specific proteins on tumor cells, potentially killing them. The study aims to determine the optimal dose and assess the treatment's safety and effectiveness. Individuals whose meningioma has returned or worsened after initial treatment, such as surgery or radiation, might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications for the RYZ101 trial?

The trial protocol does not specify if you need to stop taking your current medications. However, there is a requirement for a 28-day interval from prior chemotherapy or other systemic agents before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that RYZ101 is likely to be safe for humans?

Research suggests that RYZ101 might be safe and tolerable for treating patients with worsening or returning brain tumors called intracranial meningiomas. This treatment is a radioactive drug that targets specific tumor cells and uses radiation to destroy them. Earlier studies have shown that similar treatments were well-tolerated by patients with other types of tumors.

Currently, researchers are testing RYZ101 in an early stage of clinical trials. They are still learning about its safety and possible side effects. This phase primarily assesses the treatment's safety for people, but there isn't enough information yet to fully confirm its safety. Participants might experience side effects, which are carefully monitored throughout the trial to ensure safety.

Overall, RYZ101 appears promising, but further research will provide a clearer picture of its safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for meningioma, which often include surgery and radiation, RYZ101 offers a unique approach by targeting specific receptors on tumor cells. This treatment utilizes gallium Ga 68-DOTATATE, which helps visualize the tumor through advanced imaging techniques like PET scans, providing precise monitoring and assessment. Researchers are excited about RYZ101 because it combines targeted therapy with innovative imaging, potentially offering more effective and personalized treatment options for patients.

What evidence suggests that RYZ101 might be an effective treatment for meningioma?

Research has shown that RYZ101, a radioactive drug, may help treat certain neuroendocrine tumors. It attaches to a protein called the somatostatin receptor, found on some tumor cells. By delivering targeted radiation, it can potentially kill these cancer cells. In studies, a component of RYZ101 called intra-arterial [177Lu]Lu-DOTATATE exceeded established survival rates, indicating it might be an effective treatment. Early data also shows promising results, with some patients experiencing tumor shrinkage. Although more research is needed, these findings offer hope for those with worsening or returning intracranial meningioma. Participants in this trial will receive RYZ101 as part of their treatment regimen. ^{1 4 6 7 8}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07150806

NCT07150806 | RYZ101 for the Treatment of Progressive ... Giving RYZ101 may be safe, tolerable and/or effective in treating patients with progressive or recurrent intracranial meningioma. Detailed ...

2. aacrjournals.org aacrjournals.org/mct/article/22/12/1434/730266/RYZ101-Ac-225-DOTATATE-Opportunity-beyond

RYZ101 (Ac-225 DOTATATE) Opportunity beyond ... Furthermore, RYZ101 showed superior antitumor efficacy compared with SCLC SOC carboplatin and etoposide at clinically relevant doses, and RYZ101 in combination ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12528330/

Efficacy of Intra-arterial [177Lu]Lu-DOTATATE monotherapy ... This study supports that intra-arterial [177Lu]Lu-DOTATATE monotherapy is a safe treatment option, surpassing established survival benchmarks ...

4. researchgate.net researchgate.net/publication/371302303_ACTION-1_phase_Ib3_trial_of_RYZ101_in_somatostatin_receptor_subtype_2-expressing_SSTR2_gastroenteropancreatic_neuroendocrine_tumors_GEP-NET_progressing_after_177_Lu_somatostatin_analogue_SSA_therapy_I

ACTION-1 phase Ib/3 trial of RYZ101 in somatostatin ... Preliminary data from the Phase 1b portion of the trial reported promising efficacy, with an ORR of 29.4%, including a complete response in one patient, partial ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=59d7fe35-a57c-4c39-9859-a506607e29e6

Actinium-225 DOTATATE (RYZ101) / BMS Initial data suggest promising efficacy. Longer-term safety and efficacy data will be presented." Clinical • P1 data • Endocrine Cancer • Fatigue ...

6. withpower.com withpower.com/trial/phase-2-meningioma-10-2025-c56f3

RYZ101 for Meningioma · Info for Participants Giving RYZ101 may be safe, tolerable and/or effective in treating patients with progressive or recurrent intracranial meningioma. Show more. Who Is on the ...

7. adisinsight.springer.com adisinsight.springer.com/trials/700385754

Progressive/Recurrent Intracranial Meningioma Treated With ... This phase I/II tests the safety, side effects, best dose and how well giving RYZ101 works for the treatment of patients with intracranial ...

8. mayo.edu mayo.edu/research/clinical-trials/tests-procedures/lu-177-dotatate-therapy

Lu 177 Dotatate Therapy Clinical Trials The purpose of this study is to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, ...