Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
NCT06590857 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-03-18
Summary
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
Conditions
- Metastatic Breast Cancer
- HER2-negative Breast Cancer
- ER+ Breast Cancer
- Advanced Breast Cancer
Interventions
- DRUG
-
RYZ101
Ac-225
Sponsors & Collaborators
-
RayzeBio, Inc.
lead INDUSTRY
Principal Investigators
-
Petrus de Jong, MD, PhD · RayzeBio, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-19
- Primary Completion
- 2028-10-31
- Completion
- 2033-01-31
- FDA Drug
- Yes
Countries
- United States
- Canada
- South Korea
Study Locations
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