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).

RayzeBio, Inc.

Summary

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

Eligibility

Age range: Not specified
Sex: All
Healthy volunteers: No

Detailed criteria

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 chemother…

Interventions

Drug
RYZ101
Ac-225
Drug
Standard of Care Endocrine Therapy
Investigator's choice of endocrine therapy, such as, anastrozole, elacestrant, exemestane, fulvestrant, imlunestrant, letrozole, tamoxifen, or vepdegestrant

Summary

Eligibility

Interventions

Locations (31)