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

ClinicalTrials.gov ID: NCT06590857

Public ClinicalTrials.gov record NCT06590857. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 5, 2026, 6:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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).

Study identification

NCT ID: NCT06590857
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: RayzeBio, Inc.; Industry
Enrollment: 16 participants

Conditions and interventions

Conditions

Interventions

RYZ101 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 18, 2024
Primary completion: Sep 30, 2028
Completion: Dec 31, 2032
Last update posted: Mar 17, 2026

2024 – 2033

United States locations

U.S. sites: 25
U.S. states: 19
U.S. cities: 24

Facility	City	State	ZIP	Site status
Research Facility	Phoenix	Arizona	85054	—
Research Facility	Irvine	California	92618	—
Research Facility	San Diego	California	92093	—
Research Facility	Santa Monica	California	90404	—
Research Facility	Longmont	Colorado	80504	—
Research Facility	Jacksonville	Florida	32224	—
Research Facility	Atlanta	Georgia	30322	—
Research Facility	Indianapolis	Indiana	46202	—
Research Facility	Boston	Massachusetts	02215	—
Research Facility	Detroit	Michigan	48202	—
Research Facility	Rochester	Minnesota	55905	—
Research Facility	St Louis	Missouri	63130	—
Research Facility	Omaha	Nebraska	68124	—
Research Facility	Albuquerque	New Mexico	87109	—
Research Facility	Buffalo	New York	14203	—
Research Facility	New York	New York	10016	—
Research Facility	New York	New York	10021	—
Research Facility	Cleveland	Ohio	44195	—
Research Facility	Philadelphia	Pennsylvania	19104	—
Research Facility	Pittsburgh	Pennsylvania	15213	—
Research Facility	Dallas	Texas	75246	—
Research Facility	Houston	Texas	77024	—
Research Facility	Salt Lake City	Utah	84132	—
Research Facility	Norfolk	Virginia	23502	—
Research Facility	Seattle	Washington	98109	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06590857, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 17, 2026 · Synced May 5, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06590857 live on ClinicalTrials.gov.

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