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

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) in Subjects With Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates and/or Chemotherapy (TRACY-1).

NCT06590857•RayzeBio, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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.

Locations (31)

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

Key Dates

Start Date

July 19, 2024

Primary Completion Date

October 1, 2028

Completion Date

January 1, 2033

Last Updated

March 18, 2026

Enrollment

ACTUAL participants

Conditions

Metastatic Breast CancerHER2-negative Breast CancerER+ Breast CancerAdvanced Breast Cancer

Interventions

RYZ101

DRUG

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer

NCT07483307

Breast CancerHER2-negative Breast Cancer+2 more

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RECRUITINGPHASE1

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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