Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Phase 1

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

NCT05187832 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2022-10-05
Last updated
2026-02-27

Condition(s) studied

Advanced or Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

AND019 PO QD

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

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: 1. Postmenopausal women defined as NCCN guideline at the time of informed consent. 2. Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer women who failed standard therapy or for which no standard therapy exists. 3. Prior therapy: 1. No more than 1 line of chemotherapy for advanced breast cancer 2. Recurrence or progression on at least one line of endocrine therapy in the advanced or metastatic disease setting and derived a clinical benefit from the endocrine therapy: Recurred or progressed while being treated with adjuvant endocrine therapy for a duration of at least 24 months, or progressed under endocrine therapy for more than 6 months in the advanced or metastatic setting 4. ECOG score 0-1. 5. Minimum life expectancy of a least 3 months as determined by the Investigator. 6. Evaluable disease per RECIST 1.1; for patients consent to tissue biopsy, disease suitable for tumor biopsy. 7. Sufficient bone marrow reserve and organ function. Key Exclusion Criteria: 1. Previous treatment with any SERDs. 2. Patient any central nervous system metastasis. 3. Prior antitumor therapies: 1. Received chemotherapies within 3 weeks before the first dose. 2. Received systemic radiotherapy within 3 weeks before the first dose, or local radiotherapy within 7 days before the first dose 3. Received other anti-tumor therapy such as endocrine therapy, immunotherapy, and target therapy within 3 weeks or 5 half-lives of the drug before the first dose of the study drug 4. For bone metastasis, bisphosphonates and local remission therapy are allowed (7 days washout for local radiation therapy). 4. Patient who has participated in any other clinical trials for drugs or treatments within 5 half-lives for a prior investigational drug or 2 weeks from use of an investigational device prior to the first dose of study drug. 5. Patient who had major surgery or significant trauma within 4 weeks prior to the first dose of study drug (excluding needle biopsy), or has scheduled surgery during the study period. 6. Patient with serous unhealable wounds/ulcers/fractures within 4 weeks prior to the first dose of study drug. 7. Patient with adverse reactions to previous anti-tumor treatments who have not yet recovered to grade ≤1 according to CTCAE v5.0. (except for toxicities without safety risks as judged by Investigator, such as alopecia, grade 2 peripheral neuropathy etc.) 8. Patient who has used strong inhibitors or strong inducers of CYP3A, or grapefruit or grapefruit juice within 4 weeks prior to the first dose of study drug. 9. Patient unable to be administered oral medications or any condition that seriously affect digestion in the gastrointestinal tract at the judgement of the Investigator. 10. Patient with active infection within 1 week prior to the first dose of study drug, and currently need systemic anti-infective treatment. 11. Patient has a known history of the following: HIV infection without effective antiretroviral therapy (ART) or acceptable immune function, or syphilis infection, or HBsAg positive HBV or needs prophylaxis therapy or suppressive antiviral therapy before dosing, or has an HCV infection that hasn't completed curative antiviral treatment or with unacceptable viral load. 12. Patient has active cardiac disease or a history cardiac dysfunction. 13. Patient with third spacing that cannot be controlled clinically and is not suitable for the study by the Investigator's judgment. 14. Patient with known history of drug abuse. 15. Patient with mental disorder that, in the opinion of the Investigator, could lead to poor compliance with required study procedures. 16. Patient that cannot tolerate venous blood sampling. 17. Known to have other malignancy within the past 5 years, and is progressing or requires active treatment (except skin basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ who have received potentially radical treatment)

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Sarah Cannon Research Institute Nashville Tennessee Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05187832 on ClinicalTrials.gov ↗ ← All trials in the USA