Treatment for advanced breast cancer using RYZ101

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b/2 open-label trial evaluating the safety and efficacy of 225Ac-DOTATATE (RYZ101) in patients with ER+, HER2-negative unresectable or metastatic breast cancer that expresses somatostatin receptors (SSTRs). The study aims to enroll subjects who have measurable tumor lesions that are SSTR-PET positive and are not candidates for curative treatment. Participants will receive RYZ101 to assess its potential benefits in managing their condition.

Why it matters

Who can join: the full rules

Inclusion Criteria

Subjects must meet all the following criteria for enrollment in the study:

* Histologically confirmed, ER+, HER2-negative, locally advanced and unresectable or metastatic breast cancer not amenable to treatment with curative intent.
* Adequate renal, hematologic, and hepatic function
* Additional inclusion criteria for Monotherapy arm:

  * Measurable disease with at least 80% SSTR-positive lesions by SSTR-PET imaging
  * Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  * Documented radiologic progression after at least 2 and no more than 4 prior chemotherapy or ADC regimens in the metastatic setting
* Additional inclusion criteria for ET Combination arms:

  * Prior treatment with CDK4/6 inhibitors in combination with endocrine therapy in the advanced or metastatic setting.
  * Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  * Bone only or bone dominant disease. At least 1 bone lesion must be SSTR-positive on SSTR-PET imaging. For bone dominant disease, at least 50% of soft tissue measurable lesions must be SSTR-positive on SSTR-PET imaging. At least one bone lesion must be positive on both SSTR-PET and on FDG-PET imaging
  * Brain metastases are allowed if definitively treated and clinically stable as confirmed by interval imaging

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:

* Prior radiopharmaceutical therapy, including radioembolization.
* Any toxicities from prior treatments that have not recovered to CTCAE Grade ≤1, except for alopecia.
* Significant cardiovascular disease
* Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, spinal cord compression, or leptomeningeal disease.
* History of hypersensitivity or allergy to 225Ac, 68Ga, 64Cu, octreotate, or any of the excipients of DOTATATE imaging agents.
* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the study safety or efficacy assessments.
* Pregnancy or breastfeeding
* Additional exclusion criteria for ET Combination arms:

  * Presence of liver metastases or symptomatic metastatic visceral disease
  * Prior PARPi exposure or are candidates for PARPi per local guidelines

Where it's running

• Research Facility
  Omaha, Nebraska, United States Recruiting
• Research Facility
  Phoenix, Arizona, United States Not yet recruiting
• Research Facility
  Irvine, California, United States Not yet recruiting
• Research Facility
  San Diego, California, United States Not yet recruiting
• Research Facility
  Santa Monica, California, United States Not yet recruiting
• Research Facility
  Longmont, Colorado, United States Not yet recruiting

Study contacts

• Study coordinator: RayzeBio Clinical Trials
• Email: clinicaltrials@rayzebio.com
• Phone: 1-619-657-0057

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.