USO 24288
Phase 2 Study of Zelenectide Pevedotin in Participants with NECTIN4 Amplified Advanced Breast Cancer (BT8009-201)
Disease Types: Breast Cancer Research
Eligibility Requirements:
• Histologically or cytologically confirmed recurrent unresectable or
metastatic HER2-negative BC
• Cohort A: HR+/HER2-negative BC (HER2 IHC 2+/ISH-; IHC 1+
or IHC 0), resistant/refractory to ET
• Cohort B: TNBC, including ER-low BC (1-10% cells HR+ by IHC)
• Previously documented HER2-positive BC excluded
• Confirmed NECTIN4 gene amplification by central testing
• Prior lines of therapy (may include topoisomerase inhibitor)
• Cohort A: Up to 3 prior lines of non-ET for MBC
• Cohort B: 1-3 prior lines of systemic therapy for MBC
• Prior tx with ADC containing any MMAE payload are excluded
• Measurable disease per RECIST v1.1
For more information on this trial CLICK HERE.
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