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

Phase 1

Recruiting

• Conditions: Metastatic Breast Cancer; Advanced Breast Cancer; HER2-negative Breast Cancer; ER+ Breast Cancer
• Interventions: Drug: RYZ101

• Registration Number: NCT06590857
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-19
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2028-10
• Study Completion: 2033-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	RYZ101	RYZ101 Dose Level -1 RYZ101 Dose Level 1 RYZ101 Dose Level 2 RYZ101 Dose Level 3
Expansion	RYZ101	RYZ101 RP2D Regimen

Primary Outcome Measures

Name	Time	Method
Dose Escalation	6 weeks of RYZ101 treatment	Incidence rate of DLTs during the first 6 weeks of RYZ101 treatment
Expansion	Up to approximately 5 years after the last subject has completed RYZ101 treatment	Overall Response Rate, defined as rate of subjects achieving a Complete Response or Partial Response as determined by BICR using RECIST v1.1

Trial Locations

Locations (2)

Research Facility; 🇺🇸 Seattle, Washington, United States

Research Facilty; 🇺🇸 Salt Lake City, Utah, United States