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RecruitingPhase 1Phase 2NCT06590857

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).

Sponsor

RayzeBio, Inc.

Enrollment

124 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental radioactive drug called RYZ101 (225Ac-DOTATATE) for people with hormone receptor-positive (ER+), HER2-negative metastatic breast cancer whose tumors have a protein on their surface called somatostatin receptors (SSTRs). The drug uses radioactivity to target and destroy tumor cells. **You may be eligible if...** - You have confirmed ER-positive, HER2-negative breast cancer that has spread and cannot be surgically removed - Your tumors show positive uptake on an SSTR-PET scan (a specialized nuclear imaging scan) - Your kidneys function well (eGFR of at least 60) - Your blood counts and liver function meet the study thresholds - Your general health (ECOG performance status) is 2 or better **You may NOT be eligible if...** - You have previously received any radioactive drug therapy or radioembolization - You have significant side effects from prior treatments that have not recovered - You have active, uncontrolled brain metastases or spinal cord compression - You have significant cardiovascular disease - You have a known allergy to the components of this drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRYZ101

Ac-225

Locations(31)

Research Facility

Philadelphia, Pennsylvania, United States

Research Facility

Omaha, Nebraska, United States

Research Facility

Albuquerque, New Mexico, United States

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Jacksonville, Florida, United States

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Detroit, Michigan, United States

Research Facility

Cleveland, Ohio, United States

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Pittsburgh, Pennsylvania, United States

Research Facility

Irvine, California, United States

Research Facility

Santa Monica, California, United States

Research Facility

Longmont, Colorado, United States

Research Facility

St Louis, Missouri, United States

Research Facilty

Salt Lake City, Utah, United States

Research Facility

Indianapolis, Indiana, United States

Research Facility

Dallas, Texas, United States

Research Facility

Houston, Texas, United States

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San Diego, California, United States

Research Facility

Rochester, Minnesota, United States

Research Facility

Norfolk, Virginia, United States

Research Facility

Seoul, South Korea

Research Facility

Victoria, British Columbia, Canada

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Québec, Canada

Research Facility

Seoul, South Korea

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Seattle, Washington, United States

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Phoenix, Arizona, United States

Research Facilty

New York, New York, United States

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New York, New York, United States

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Atlanta, Georgia, United States

Research Facility

Buffalo, New York, United States

Research Facility

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06590857

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