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

ConditionsMetastatic Breast CancerHER2-negative Breast CancerER+ Breast CancerAdvanced Breast CancerMetastatic Breast Cancer With Bone InvolvementBone Metastases in Subjects With Advanced Breast CancerER-Positive HER2-Negative Breast CancerEstrogen Receptor-positive Breast CancerHormone-sensitive Metastatic Breast CancerHormone-Sensitive Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRayzeBio, Inc.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Measurable disease with at least 80% SSTR-positive lesions by SSTR-PET imaging

Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • RYZ101

    Drug

    Ac-225

  • Standard of Care Endocrine Therapy

    Drug

    Investigator's choice of endocrine therapy, such as, anastrozole, elacestrant, exemestane, fulvestrant, imlunestrant, letrozole, tamoxifen, or vepdegestrant

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Endocrine Therapy Combination Dose Escalation and ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose Escalation

Incidence rate of DLTs during the first 6 weeks of RYZ101 treatment

Time frame
6 weeks of RYZ101 treatment
2

Endocrine Therapy Combination Dose Escalation

Incidence rate of DLTs during the first 6 weeks of study treatment

Time frame
[Time Frame: 6 weeks of study treatment]
3

Endocrine Therapy Combination Dose Escalation

Incidence and severity of treatment emergent AEs by NCI-CTCAE v5.0

Time frame
Up to approximately 5 years after the last subject has completed RYZ101 treatment
4

Endocrine Therapy Combination Dose Escalation and Expansion

Progression Free Survival, defined as the time between first dose of study treatment and progression or death, as assessed by the investigator per RECIST v1.1 criteria

Time frame
Up to approximately 5 years after the last subject has completed RYZ101 treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RayzeBio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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