USO 24026
Phase 1b/2 open-label trial of 225 Ac-DOTATATE (RYZ101) alone and in combination with pembrolizumab 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) and progressed after antibody-drug conjugates and/or chemotherapy (TRACY-1).(RYZ101-201)
Disease Types: Breast Cancer Research
Eligibility Requirements:
ER+/ HER2- MBC
• ER ≥1%, HER2 IHC 0 or 1+, or 2+ and ISH negative
• Archival or fresh tumor tissue for central biomarker analysis
• Endocrine refractory
• Documented progression after 2-4 prior chemo or ADC
regimens in metastatic setting (at least 1 prior line of therapy
must be ADC)
• Prior anti PD-(L)1 or PD-L2 therapy or agent directed to
another stimulatory or co-inhibitory T-cell receptor excluded
• ≥1 measurable lesion (RECIST v1.1) that is SSTR-PET positive
• At least 80% of measurable lesions are SSTR-PET positive
within 90 days of enrollment
For more information on this trial CLICK HERE .
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