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

NCT05187832 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Advanced or Metastatic Breast Cancer

Interventions

DRUG

AND019 PO QD

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

Sponsors & Collaborators

  • Kind Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Yusha Zhu, MD PhD · Kind Pharmaceuticals LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05187832 on ClinicalTrials.gov