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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

This trial does not accept healthy volunteers

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 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 alpha radiopharmaceutical therapies (RPT), including radioembolization

Trial design

Design model

Single group

Treatments tested in this trial

  • Actinium Ac 225 DOTATATE RYZ101

    Drug

    Given IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • Gallium Ga 68-DOTATATE

    Radiation

    Given IV

  • L-lysine/L-arginine-containing Amino Acid

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA scan

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Somatostatin Receptor Positron Emission Tomography

    Procedure/Surgery

    Undergo SSTR PET scan

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment (RYZ101)Experimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Defined as survival without progression of disease (progressive disease, based on Response Assessment in Neuro-Oncology Criteria \[RANO\] 2.0 criteria) or death. Kaplan-Meier analyses will be used to estimate PFS.

Time frame
At 6 months

Secondary outcomes

1

Objective response rate (ORR)

Assessed by standard of care brain magnetic resonance imaging (MRI) at 6 months and gallium Ga 68-DOTATATE positron emission tomography (PET) at 1 year. ORR defined as the best response including complete response, partial response or stable disease per RANO 2.0 criteria.

Time frame
At 6 months and 1 year
2

Overall survival (OS)

Kaplan-Meier analyses will be used to estimate OS.

Time frame
From the date of trial enrolment to date of death, up to 2 years
3

Incidence of adverse events

The number and type of adverse events will be summarized, using the NCI's Common Toxicity Criteria for Adverse Events, version 5.0 (CTCAE V.5.0).

Time frame
Up to 2 years
4

PET standardized uptake value uptake

To compare to the background for treatment response assessment and as a potential biomarker of response and prognosis.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joshua Palmer

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

RayzeBio, Inc.

Collaborator

Source ClinicalTrials.gov
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