RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Joshua Palmer
Study ID
NCT07150806
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Meningioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Actinium Ac 225 DOTATATE RYZ101 — DRUG
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Gallium Ga 68-DOTATATE — RADIATION
    Given IV
  • L-lysine/L-arginine-containing Amino Acid — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Somatostatin Receptor Positron Emission Tomography — PROCEDURE
    Undergo SSTR PET scan

Study Details

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.

Key Dates

Start date
Nov 12, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (RYZ101)
    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.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: At 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Joshua D. Palmer, MD
[email protected]
614-293-0871
Joshua D. Palmer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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