Kind Pharmaceuticals LLC
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.
Key Inclusion Criteria: 1. Postmenopausal women defined as NCCN guideline at the time of informed consent. 2. Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer women who failed standard therapy or for which no standard therapy exists. 3. Prior therapy: 1. No more than 1 line of chemotherapy for advanced breast cancer 2. 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…
AND019 administrated as oral capsule once per day for 28 days for each cycle
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