Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer

In brief

Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.

Key facts

Study ID

NCT06590857

Run by

RayzeBio, Inc.

People needed

16

Starts

2024-07-19

Expected to finish

2033-01-01

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all the following criteria for enrollment in the study:
• 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

You may not qualify if…

• Subjects who meet any of the following criteria will be excluded from the study:
• 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.

Where it is running

• Research Facility — Phoenix, Arizona, United States
• Research Facility — Irvine, California, United States
• Research Facility — San Diego, 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 — Albuquerque, New Mexico, United States
• Research Facility — Buffalo, New York, United States
• Research Facility — 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 Facility — Salt Lake City, Utah, United States
• Research Facility — Norfolk, Virginia, United States
• Research Facility — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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