Phase I Study of AND019 Capsules in Postmenopausal Women With Advanced or Metastatic ER-Positive, HER2-Negative Breast Cancer Evaluating Safety, Dose, and Early Treatment Effects

What this Trial Is About

Researchers are evaluating AND019 in postmenopausal women with advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer. This first-in-human study aims to assess the safety, tolerability, how the drug moves and acts in the body, and early signs of anti-tumor activity. The study focuses on women who have failed standard therapy or have no standard treatment options available. Participants will receive oral capsules of AND019 once daily, with doses ranging from 20 mg to 400 mg during the initial dose escalation phase. After this, two dose levels will be chosen for further evaluation in an expansion phase. Each treatment cycle lasts 28 days, and dosing continues under close monitoring. Throughout the study, participants will undergo assessments including monitoring for side effects up to 12 weeks after their last dose, pharmacokinetic testing at specific days in the first cycle and subsequent cycles, and evaluations of tumor response every 8 to 12 weeks for up to 24 months. Researchers will also track clinical benefit and duration of response. Safety and organ function will be regularly checked, with participation lasting up to about two years depending on treatment continuation and follow-up.

A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer