NCT06590857

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).

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: RayzeBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	RYZ101	Ac-225

Timeline

• Start date: 2024-07-19
• Primary completion: 2028-10-01
• Completion: 2033-01-01
• First posted: 2024-09-19
• Last updated: 2026-03-18

Locations

31 sites across 3 countries: United States, Canada, South Korea

Regulatory

• FDA-regulated drug study