RecruitingPhase 1NCT05187832

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

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


Sponsor

Kind Pharmaceuticals LLC

Enrollment

61 participants

Start Date

Oct 5, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new oral drug called AND019 in postmenopausal women with hormone receptor-positive (ER+), HER2-negative advanced or metastatic breast cancer that has progressed on prior hormone therapy. **You may be eligible if...** - You are a postmenopausal woman with ER-positive, HER2-negative advanced or metastatic breast cancer - Your cancer has progressed on at least one prior hormone therapy - You have received no more than one prior chemotherapy regimen for advanced disease - You are in good general health (ECOG 0 or 1) - Your organs are functioning well enough to tolerate treatment **You may NOT be eligible if...** - You have previously been treated with a SERD (selective estrogen receptor degrader) drug - You have brain metastases - You have received chemotherapy, immunotherapy, or targeted therapy recently - You have a history of significant heart disease - You are currently pregnant or breastfeeding - You have active, uncontrolled infection or HIV without effective treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAND019 PO QD

AND019 administrated as oral capsule once per day for 28 days for each cycle


Locations(1)

Sarah Cannon Research Institute

Nashville, Tennessee, United States

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NCT05187832


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