Testing RYZ101 for metastatic breast cancer
Official title: 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 Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) (TRACY-1).
- Phase 1
- 2 groups
- Sites in Victoria, Toronto and 1 more city
- Recruiting
Interventions
- Medication
RYZ101
Ac-225
- Medication
Standard of Care Endocrine Therapy
Investigator's choice of endocrine therapy, such as, anastrozole, elacestrant, exemestane, fulvestrant, imlunestrant, letrozole, tamoxifen, or vepdegestrant
Canadian Sites (4)
4 listed, none recruiting
- Not yet recruiting
Research Facility
Victoria, British Columbia
- Not yet recruiting
Research Facility
Toronto, Ontario
- Not yet recruiting
Research Facility
Toronto, Ontario
- Not yet recruiting
Research Facility
Québec, Quebec
Eligibility Criteria
See who this study is looking for35 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +History of hypersensitivity or allergy to 225Ac, 68Ga, 64Cu, octreotate, or any of the excipients of DOTATATE imaging agents.
- +Brain metastases are allowed if definitively treated and clinically stable as confirmed by interval imaging
- +Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, spinal cord compression, or leptomeningeal disease.
- +Subjects must meet all the following criteria for enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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 criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for Monotherapy armArmOne of the groups in a study, each receiving something different.Read more →:
- +Measurable disease with at least 80% SSTR-positive lesions by SSTR-PET imaging
- +Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- +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
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +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
- +Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the study safety or efficacy assessments.
- +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
- +Pregnancy or breastfeeding
- +Documented radiologic progression after at least 2 and no more than 4 prior chemotherapy or ADC regimens in the metastatic setting
Exclusion
- −History of hypersensitivity or allergy to 225Ac, 68Ga, 64Cu, octreotate, or any of the excipients of DOTATATE imaging agents.
- −Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, spinal cord compression, or leptomeningeal disease.
- −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
- −Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the study safety or efficacy assessments.
- −Additional exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for ET Combination armsArmOne of the groups in a study, each receiving something different.Read more →:
- −Presence of liver metastases or symptomatic metastatic visceral disease
- −Prior PARPi exposure or are candidates for PARPi per local guidelines
- −Pregnancy or breastfeeding
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives RYZ101.
Registry label: A: Monotherapy Dose Escalation
Group B receives one or more of: RYZ101 and Standard of CareStandard of careThe treatment normally given for a condition outside a study.Read more → Endocrine Therapy.
Registry label: B: Endocrine Therapy Combination Dose Escalation and Expansion
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 64 people.
The study is currently expected to finish around November 2033.
The main measurement is taken over: 6 weeks of RYZ101 treatment.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Dose EscalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more → — measured over 6 weeks of RYZ101 treatment.
Endocrine Therapy Combination Dose Escalation — measured over [Time Frame: 6 weeks of study treatment].
Endocrine Therapy Combination Dose Escalation — measured over Up to approximately 5 years after the last subject has completed RYZ101 treatment.
Endocrine Therapy Combination Dose Escalation and Expansion — measured over Up to approximately 5 years after the last subject has completed RYZ101 treatment.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06590857 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About RYZ101Drug
Ac-225
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Standard of Care Endocrine TherapyDrug
Investigator's choice of endocrine therapy, such as, anastrozole, elacestrant, exemestane, fulvestrant, imlunestrant, letrozole, tamoxifen, or vepdegestrant
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 6 weeks of RYZ101 treatment.
The study as a whole is currently expected to finish around 2033-11.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 64 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 8 locations, including: Victoria, British Columbia, Canada; Toronto, Ontario, Canada; Québec, Quebec, Canada; Detroit, Michigan, United States; Rochester, Minnesota, United States; Buffalo, New York, United States, and 2 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
Other Sites (6)
Research Facility
Detroit, Michigan, United States
Research Facility
Rochester, Minnesota, United States
Research Facility
Buffalo, New York, United States
Research Facility
New York, New York, United States
Research Facility
New York, New York, United States
Research Facility
Seattle, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.