Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06590857 · ClinicalTrials.gov registry record · Phase 1
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
A Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, sponsored by RayzeBio.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 20
- Study locations
NCT06590857: Active Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, sponsored by RayzeBio.
NCT06590857 is a Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer that is active but no longer recruiting, run by RayzeBio. The registered enrollment target is 16 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06590857, a Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, is active but no longer recruiting, sponsored by RayzeBio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
Primary Outcome
Incidence rate of DLTs during the first 6 weeks of RYZ101 treatment
Conditions Studied
Interventions
- DRUG RYZ101
Study Locations (20)
California
- Research Facility - Irvine
- Research Facility - San Diego
- Research Facility - Santa Monica
New York
- Research Facility - Buffalo
- Research Facility - New York
- Research Facility - New York
Pennsylvania
- Research Facility - Philadelphia
- Research Facility - Pittsburgh
Arizona
- Research Facility - Phoenix
Colorado
- Research Facility - Longmont
Florida
- Research Facility - Jacksonville
Georgia
- Research Facility - Atlanta
Indiana
- Research Facility - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-07-19 |
| Est. Completion | 2033-01 |
| Phase | Phase 1 |
What the registry record for NCT06590857 still lists
NCT06590857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which RYZ101 is the first listed.
NCT06590857 names 20 study sites across 15 states, led by California, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06590857 about?
NCT06590857 is a clinical study titled "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 ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
What is the current status of trial NCT06590857?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2024-07-19. Estimated completion is 2033-01.
What conditions does trial NCT06590857 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, HER2-Negative Breast Cancer, Advanced Breast Cancer, ER+ Breast Cancer.
What interventions are being tested in trial NCT06590857?
The interventions under investigation include: RYZ101 (DRUG).
Who is sponsoring clinical trial NCT06590857?
This trial is sponsored by RayzeBio, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06590857 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06590857's enrollment target sits among peer trials
16 126th of 139 higher than 13 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
RECRUITING · Phase 1
-
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
RECRUITING · Phase 1
-
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
RECRUITING · Phase 1
-
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
RECRUITING · Phase 1
-
PRE-I-SPY Phase I/Ib Oncology Platform Program
RECRUITING · Phase 1
-
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
- NCT03858751 · 16 participants · Phase 1
Pharmacological Activation of HMN for OSA Aim 2
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI