Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
NCT05187832

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

Led by Kind Pharmaceuticals LLC · Updated on 2026-02-27

61

Participants Needed

1

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women as defined by NCCN guidelines at consent
  • Confirmed advanced or metastatic estrogen receptor positive and HER2 negative breast cancer
  • Failed standard therapy or no standard therapy available
  • No more than one prior chemotherapy line for advanced breast cancer
  • Recurrence or progression during or after endocrine therapy with clinical benefit
  • ECOG performance status 0 or 1
  • Life expectancy of at least 3 months
  • Measurable disease per RECIST 1.1; suitable for tumor biopsy if consenting
  • Adequate bone marrow reserve and organ function
Not Eligible

You will not qualify if you...

  • Previous treatment with selective estrogen receptor degraders (SERDs)
  • Presence of central nervous system metastases
  • Chemotherapy within 3 weeks before first dose
  • Systemic radiotherapy within 3 weeks or local radiotherapy within 7 days before first dose
  • Other anti-tumor therapy within 3 weeks or 5 half-lives before first dose
  • Participation in other clinical trials with investigational drugs or devices within specified washout periods
  • Major surgery or significant trauma within 4 weeks before first dose or planned surgery during study
  • Serious wounds, ulcers, or fractures within 4 weeks before first dose
  • Unresolved adverse reactions to prior anti-tumor treatments above grade 1 (except certain low-risk toxicities)
  • Use of strong CYP3A inhibitors or inducers, or grapefruit products within 4 weeks before first dose
  • Inability to take oral medications or serious gastrointestinal conditions
  • Active infection requiring systemic treatment within 1 week before first dose
  • Uncontrolled HIV, syphilis, hepatitis B or C infections
  • Active cardiac disease or history of cardiac dysfunction
  • Uncontrolled fluid accumulation (third spacing)
  • History of drug abuse
  • Mental disorders affecting compliance
  • Intolerance to venous blood sampling
  • Other malignancies within 5 years requiring treatment or progressing (except certain skin or cervical cancers treated with curative intent)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Actively Recruiting

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Research Team

Y

Yusha Zhu, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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