Status:
RECRUITING
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Lead Sponsor:
RayzeBio, Inc.
Conditions:
Metastatic Breast Cancer
HER2-negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2033
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06590857
Start Date
July 19 2024
End Date
January 1 2033
Last Update
August 12 2025
Active Locations (23)
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1
Research Facility
Phoenix, Arizona, United States, 85054
2
Research Facility
Irvine, California, United States, 92618
3
Research Facility
Santa Monica, California, United States, 90404
4
Research Facility
Longmont, Colorado, United States, 80504