Active — Not RecruitingPhase 1/2

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

United States, Canada, South Korea16 participantsStarted 2024-07-19

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Subjects must meet all the following criteria for enrollment in the study: * Eastern Cooperative Oncology Group performance status ≤2. * Histologically confirmed, ER+, HER2-negative, locally advanced and unresectable or metastatic breast cancer not amenable to treatment with curative intent. * At least one RECIST v1.1-measurable tumor lesion that is SSTR-PET positive (defined as maximum standard uptake value (SUVmax) higher than liver mean standard uptake value (SUVmean) on SSTR-PET imaging) and at least 80% of RECIST v1.1measurable tumor lesions are SSTR-PET positive * Sufficient renal function, as evidenced by eGFR ≥60 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation * Adequate hematologic and hepatic function 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses a radioactive drug called 225Ac-DOTATATE, which targets something called somatostatin receptors — do I know whether my tumor actually expresses these receptors, and if not, is there a test my team can do to find out?
2Since this is a Phase 1/2 trial that was still in the dose-escalation stage, what does that mean for how much is known about the safety of this treatment, and what side effects should I be most concerned about discussing?
3The trial is listed as 'active not recruiting,' which means they're no longer accepting new patients — is there any chance my doctor could still connect me with this research team, or are there similar trials using targeted radioligand therapy that I might be eligible for?
4How does this approach of using a radioactive drug compare to the standard hormone-based or CDK4/6 inhibitor treatments typically offered for ER-positive, HER2-negative metastatic breast cancer — and where would this fit in my overall treatment plan?
5What would the practical demands of participating in a radioligand therapy trial like this look like in terms of hospital visits, radiation safety precautions at home, and monitoring appointments, and is that something my situation could realistically accommodate?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose Escalation

Timeframe: 6 weeks of RYZ101 treatment

Expansion

Timeframe: Up to approximately 5 years after the last subject has completed RYZ101 treatment

Trial details

NCT IDNCT06590857

SponsorRayzeBio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10

View on ClinicalTrials.gov More Metastatic Breast Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.