Lead Sponsor

RayzeBio, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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

•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.

Related studies

NCT05468034 · Breast Cancer, Indolent Metastatic Breast Cancer

NCT07347600 · Locally Advanced Breast Cancer, Metastatic Breast Cancer

NCT07085767 · Breast Cancer, Locally Advanced Breast Cancer, and more

NCT06681064 · Breast Cancer, Triple Negative Breast Cancer, and more

NCT05467891 · Locoregional Recurrence, Hormone Receptor-positive Breast Cancer, and more

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