Trials / Recruiting
RecruitingNCT05187832
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (estimated)
- Sponsor
- Kind Pharmaceuticals LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AND019 PO QD | AND019 administrated as oral capsule once per day for 28 days for each cycle |
Timeline
- Start date
- 2022-10-05
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2022-01-12
- Last updated
- 2026-02-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05187832. Inclusion in this directory is not an endorsement.