Health Trials

RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma

ConditionRecurrent Meningioma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJoshua Palmer

About this trial

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.

Eligibility criteria

Qualifiers

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.

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 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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Actinium Ac 225 DOTATATE RYZ101
  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography Test
  • Gallium Ga 68-DOTATATE
  • L-lysine/L-arginine-containing Amino Acid
  • Magnetic Resonance Imaging
  • Multigated Acquisition Scan
  • Positron Emission Tomography
  • Somatostatin Receptor Positron Emission Tomography

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Joshua Palmer

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

RayzeBio, Inc.

Collaborator

Source ClinicalTrials.gov