Back to search results

A Study of AND019 for ER Positive HER2 Negative Advanced or Metastatic Breast Cancer

This study is testing a new oral medicine called AND019 for women with advanced or metastatic breast cancer that is Estrogen Receptor-positive (ER+) and HER2-negative. This means the cancer cells have receptors for estrogen but not for HER2. AND019 is an immunotherapy, which helps your body's immune system fight cancer. The study aims to understand how safe AND019 is, how well your body handles it, and if it shows early signs of shrinking tumors. You may be eligible if you are a postmenopausal woman whose cancer has not responded to standard treatments or for whom no standard treatment exists. The study is currently recruiting about 61 participants.

Study design
This is a first-in-human study to find the right dose and further evaluate AND019. It will include about 61 postmenopausal women.
What's involved
You would take AND019 as an oral capsule once daily for 28 days in each cycle. Blood samples for drug levels would be taken at specific times during the first cycle and at the start of later cycles.
Compensation
Not stated in the trial record.
Follow-up
Your health and any side effects will be monitored from the start of the study until 12 weeks after your last dose of AND019, for up to 25 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05187832

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kind Pharmaceuticals LLC
~61 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:AND019 PO QD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events by severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Measured over From baseline to 12 weeks after the last dose of study treatment (up to 25 months)
+1 more outcome measured

Conditions

Advanced or Metastatic Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Yusha Zhu, MD PhD · STUDY_DIRECTOR · Kind Pharmaceuticals LLC

Who to contact

Yusha Zhu, MD PhD
[email protected]
6467252552
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Number of participants with adverse events by severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0From baseline to 12 weeks after the last dose of study treatment (up to 25 months)

    Number of participants with adverse events

  • PK study of AND019At 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