A Phase I Dose Escalation and Dose Expansion Study of AND019 in Patients With Estrogen Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative Advanced or Metastatic Breast Cancer
This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 \[HER2\]-negative) breast cancer.
• Postmenopausal women defined as NCCN guideline at the time of informed consent.
• Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer women who failed standard therapy or for which no standard therapy exists.
• Prior therapy:
‣ No more than 1 line of chemotherapy for advanced breast cancer
⁃ Recurrence or progression on at least one line of endocrine therapy in the advanced or metastatic disease setting and derived a clinical benefit from the endocrine therapy: Recurred or progressed while being treated with adjuvant endocrine therapy for a duration of at least 24 months, or progressed under endocrine therapy for more than 6 months in the advanced or metastatic setting
• ECOG score 0-1.
• Minimum life expectancy of a least 3 months as determined by the Investigator.
• Evaluable disease per RECIST 1.1; for patients consent to tissue biopsy, disease suitable for tumor biopsy.
• Sufficient bone marrow reserve and organ function.