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A Phase 1/2, Open-label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of ARV-471 in Patients with ER+/HER2- Locally Advanced or Metastatic Breast Cancer, Who Have Received Prior Hormonal Therapy and Chemotherapy in the Locally Advanced/Metastatic Setting
This is a first in human, dose escalation study and will assess the safety and tolerability of ARV-471 in woman and men with ER+/HER2- locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.
Primary: To evaluate the safety and tolerability of ARV-471in successive cohorts of patients in order to estimate the maximum tolerated dose and select the recommended phase 2 dose/schedule. Secondary: To characterize the single dose and steady-state PK of ARV-471 and ARV-473 (an epimer of ARV-471). To explore preliminary anti-tumor activity.
772256 (Palbociclib); ARV-471 (); Palbociclib ()