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NCT06590857 | RECRUITING | Metastatic Breast Cancer

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

RayzeBio, Inc.

Brief Summary:

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

Condition or disease

Metastatic Breast Cancer

HER2-negative Breast Cancer

Is+ breast cancer

Advanced Breast Cancer

Intervention/treatment

RYZ101

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 124 participants
Masking : NONE
Primary Purpose : TREATMENT
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).
Actual Study Start Date : 2024-07-19
Estimated Primary Completion Date : 2028-10
Estimated Study Completion Date : 2033-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
    • Trial of 225Ac-DOTATATE (RYZ101) in Subjects with ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.

    Location Details

    NCT06590857

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    NOT YET RECRUITING

    United States, Arizona

    Research Facility

    Phoenix, Arizona, United States, 85054

    RECRUITING

    United States, California

    Research Facility

    Irvine, California, United States, 92618

    RECRUITING

    United States, California

    Research Facility

    Santa Monica, California, United States, 90404

    RECRUITING

    United States, Colorado

    Research Facility

    Longmont, Colorado, United States, 80504

    NOT YET RECRUITING

    United States, Florida

    Research Facility

    Jacksonville, Florida, United States, 32224

    NOT YET RECRUITING

    United States, Georgia

    Research Facility

    Atlanta, Georgia, United States, 30322

    RECRUITING

    United States, Indiana

    Research Facility

    Indianapolis, Indiana, United States, 46202

    RECRUITING

    United States, Massachusetts

    Research Facility

    Boston, Massachusetts, United States, 02215

    NOT YET RECRUITING

    United States, Road cancer

    Research Facility

    Detroit, Road cancer, United States, 48202

    NOT YET RECRUITING

    United States, Minnesota

    Research Facility

    Rochester, Minnesota, United States, 55905

    RECRUITING

    United States, Missouri

    Research Facility

    Saint Louis, Missouri, United States, 63130

    RECRUITING

    United States, Nebraska

    Research Facility

    Omaha, Nebraska, United States, 68124

    NOT YET RECRUITING

    United States, New York

    Research Facility

    Buffalo, New York, United States, 14203

    NOT YET RECRUITING

    United States, New York

    Research Facilty

    New York, New York, United States, 10016

    RECRUITING

    United States, New York

    Research Facility

    New York, New York, United States, 10021

    NOT YET RECRUITING

    United States, Ohio

    Research Facility

    Cleveland, Ohio, United States, 44195

    NOT YET RECRUITING

    United States, Pennsylvania

    Research Facility

    Philadelphia, Pennsylvania, United States, 19104

    NOT YET RECRUITING

    United States, Pennsylvania

    Research Facility

    Pittsburg, Pennsylvania, United States, 15213

    RECRUITING

    United States, Texas

    Research Facility

    Dallas, Texas, United States, 75246

    RECRUITING

    United States, Texas

    Research Facility

    Houston, Texas, United States, 77024

    RECRUITING

    United States, Utah

    Research Facilty

    Salt Lake City, Utah, United States, 84132

    RECRUITING

    United States, Virginia

    Research Facility

    Norfolk, Virginia, United States, 23502

    RECRUITING

    United States, Washington

    Research Facility

    Seattle, Washington, United States, 98109