Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
NCT ID: NCT06590857
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
124 participants
INTERVENTIONAL
2024-07-19
2033-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
RYZ101 Dose Level -1
RYZ101 Dose Level 1
RYZ101 Dose Level 2
RYZ101 Dose Level 3
RYZ101
Ac-225
Expansion
RYZ101 RP2D Regimen
RYZ101
Ac-225
Interventions
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RYZ101
Ac-225
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group performance status ≤2.
* Histologically confirmed, ER+, HER2-negative, locally advanced and unresectable or metastatic breast cancer not amenable to treatment with curative intent.
* At least one RECIST v1.1-measurable tumor lesion that is SSTR-PET positive (defined as maximum standard uptake value (SUVmax) higher than liver mean standard uptake value (SUVmean) on SSTR-PET imaging) and at least 80% of RECIST v1.1measurable tumor lesions are SSTR-PET positive
* Sufficient renal function, as evidenced by eGFR ≥60 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
* Adequate hematologic and hepatic function
Exclusion Criteria
* Prior radiopharmaceutical therapy, including radioembolization.
* Any toxicities from prior treatments that have not recovered to CTCAE Grade ≤1, except for alopecia.
* Significant cardiovascular disease
* Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, spinal cord compression, or leptomeningeal disease.
* History of hypersensitivity or allergy to 225Ac, 68Ga, 64Cu, octreotate, or any of the excipients of DOTATATE imaging agents.
* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the study safety or efficacy assessments.
* Pregnancy or lactation.
18 Years
ALL
No
Sponsors
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RayzeBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Denis Ferreira, MD
Role: STUDY_DIRECTOR
RayzeBio, Inc.
Locations
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Research Facility
Phoenix, Arizona, United States
Research Facility
Irvine, California, United States
Research Facility
Santa Monica, California, United States
Research Facility
Longmont, Colorado, United States
Research Facility
Jacksonville, Florida, United States
Research Facility
Atlanta, Georgia, United States
Research Facility
Indianapolis, Indiana, United States
Research Facility
Boston, Massachusetts, United States
Research Facility
Detroit, Michigan, United States
Research Facility
Rochester, Minnesota, United States
Research Facility
St Louis, Missouri, United States
Research Facility
Omaha, Nebraska, United States
Research Facility
Buffalo, New York, United States
Research Facilty
New York, New York, United States
Research Facility
New York, New York, United States
Research Facility
Cleveland, Ohio, United States
Research Facility
Philadelphia, Pennsylvania, United States
Research Facility
Pittsburgh, Pennsylvania, United States
Research Facility
Dallas, Texas, United States
Research Facility
Houston, Texas, United States
Research Facilty
Salt Lake City, Utah, United States
Research Facility
Norfolk, Virginia, United States
Research Facility
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RYZ101-201
Identifier Type: -
Identifier Source: org_study_id
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