RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.

Official Title

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).

Quick Facts

Study Start:2024-07-19
Study Completion:2033-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06590857

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

RayzeBio Clinical Trials
CONTACT
(619) 657-0302
clinicaltrials@rayzebio.com

Principal Investigator

Denis Ferreira, MD
STUDY_DIRECTOR
RayzeBio, Inc.

Study Locations (Sites)

Research Facility
Phoenix, Arizona, 85054
United States
Research Facility
Irvine, California, 92618
United States
Research Facility
Santa Monica, California, 90404
United States
Research Facility
Longmont, Colorado, 80504
United States
Research Facility
Jacksonville, Florida, 32224
United States
Research Facility
Atlanta, Georgia, 30322
United States
Research Facility
Indianapolis, Indiana, 46202
United States
Research Facility
Boston, Massachusetts, 02215
United States
Research Facility
Detroit, Michigan, 48202
United States
Research Facility
Rochester, Minnesota, 55905
United States
Research Facility
Saint Louis, Missouri, 63130
United States
Research Facility
Omaha, Nebraska, 68124
United States
Research Facility
Buffalo, New York, 14203
United States
Research Facilty
New York, New York, 10016
United States
Research Facility
New York, New York, 10021
United States
Research Facility
Cleveland, Ohio, 44195
United States
Research Facility
Philadelphia, Pennsylvania, 19104
United States
Research Facility
Pittsburg, Pennsylvania, 15213
United States
Research Facility
Dallas, Texas, 75246
United States
Research Facility
Houston, Texas, 77024
United States
Research Facilty
Salt Lake City, Utah, 84132
United States
Research Facility
Norfolk, Virginia, 23502
United States
Research Facility
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: RayzeBio, Inc.

  • Denis Ferreira, MD, STUDY_DIRECTOR, RayzeBio, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-19
Study Completion Date2033-01

Study Record Updates

Study Start Date2024-07-19
Study Completion Date2033-01

Terms related to this study

Keywords Provided by Researchers

  • Actinium
  • Alpha-Emitter
  • SSTR+ MBC
  • ER+, HER2-, MBC
  • RYZ101
  • 225Ac
  • Targeted Radiotherapy
  • Radiopharmaceutical
  • SSTR+ ABC
  • ER+, HER2-, ABC

Additional Relevant MeSH Terms

  • Metastatic Breast Cancer
  • HER2-negative Breast Cancer
  • ER+ Breast Cancer
  • Advanced Breast Cancer