Actively Recruiting
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
Led by Kind Pharmaceuticals LLC · Updated on 2026-02-27
61
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AND019 in postmenopausal women with advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer. This first-in-human study aims to assess the safety, tolerability, how the drug moves and acts in the body, and early signs of anti-tumor activity. The study focuses on women who have failed standard therapy or have no standard treatment options available. Participants will receive oral capsules of AND019 once daily, with doses ranging from 20 mg to 400 mg during the initial dose escalation phase. After this, two dose levels will be chosen for further evaluation in an expansion phase. Each treatment cycle lasts 28 days, and dosing continues under close monitoring. Throughout the study, participants will undergo assessments including monitoring for side effects up to 12 weeks after their last dose, pharmacokinetic testing at specific days in the first cycle and subsequent cycles, and evaluations of tumor response every 8 to 12 weeks for up to 24 months. Researchers will also track clinical benefit and duration of response. Safety and organ function will be regularly checked, with participation lasting up to about two years depending on treatment continuation and follow-up.
CONDITIONS
Brief Title
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women as defined by NCCN guidelines at the time of consent
- Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer
- Failed standard therapy or no standard therapy exists
- No more than 1 line of chemotherapy for advanced breast cancer
- Recurrence or progression on at least one line of endocrine therapy in advanced or metastatic disease with clinical benefit from endocrine therapy
- ECOG performance status of 0-1
- Minimum life expectancy of at least 3 months
- Evaluable disease per RECIST 1.1; suitable disease for tumor biopsy if consenting
- Sufficient bone marrow reserve and organ function
You will not qualify if you...
- Previous treatment with any selective estrogen receptor degraders (SERDs)
- Presence of central nervous system metastasis
- Chemotherapy within 3 weeks before first dose
- Systemic radiotherapy within 3 weeks or local radiotherapy within 7 days before first dose
- Other anti-tumor therapies within 3 weeks or 5 half-lives before first dose (except bisphosphonates and local remission therapy for bone metastasis with 7 days washout)
- Participation in other clinical trials within 5 half-lives for drugs or 2 weeks for devices before first dose
- Major surgery or significant trauma within 4 weeks before first dose or scheduled surgery during study
- Unhealed wounds, ulcers, or fractures within 4 weeks before first dose
- Unresolved adverse reactions from previous 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
- Unable to take oral medications or serious gastrointestinal conditions
- Active infection requiring systemic treatment within 1 week before first dose
- History of uncontrolled HIV, syphilis, hepatitis B or C infections
- Active cardiac disease or history of cardiac dysfunction
- Uncontrolled third spacing
- History of drug abuse
- Mental disorders affecting compliance
- Intolerance to venous blood sampling
- Other malignancies within 5 years requiring active treatment, except certain skin and cervical cancers
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive AND019 oral capsules once daily in 28-day cycles as the study treatment.
Visits at Day 1, Day 8, Day 15, and Day 22 of Cycle 1, and Day 1 of each cycle starting from Cycle 2
Duration - Up to 12 weeks after the last dose
Participants are monitored for safety and treatment outcomes for up to 12 weeks after the last dose of study treatment.
Visits approximately every 4 weeks during follow-up
Trial Site Locations
Total: 1 location
1
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
Y
Yusha Zhu, MD PhD
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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