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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.
Details
| Lead sponsor | Kind Pharmaceuticals LLC |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 61 |
| Start date | 2022-10-05 |
| Completion | 2026-11 |
Conditions
- Advanced or Metastatic Breast Cancer
Interventions
- AND019 PO QD
Primary outcomes
- Number of participants with adverse events by severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 — From baseline to 12 weeks after the last dose of study treatment (up to 25 months)
Number of participants with adverse events - PK study of AND019 — At predefined timepoints at Day 1, Day 8, Day 15, and Day 22 of Cycle 1, and Day 1 of each cycle starting from Cycle 2 (each cycle is 28 days)
Plasma concentration of AND019 over time
Countries
United States