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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
AND019 administrated as oral capsule once per day for 28 days for each cycle
Sarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGNumber of participants with adverse events by severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Number of participants with adverse events
Time frame: From baseline to 12 weeks after the last dose of study treatment (up to 25 months)
PK study of AND019
Plasma concentration of AND019 over time
Time frame: 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)
Determine the RP2D
To observe the dose limiting toxicity (DLT) and maximum tolerated dose MTD to determine RP2D.
Time frame: From baseline to up to the end of Cycle 1 (each cycle is 28 days)
Percentage of Participants with Objective Response
ORR is defined as a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Baseline and every 8 weeks from Cycle 1 Day 1 until Week 24, and then every 12 weeks until end of study treatment (up to 24 months) (each cycle is 28 days)
Clinical Benefit Rate
CBR is defined as the percentage of participants achieving either of the following: confirmed complete response or partial response (as determined by the investigator according to RECIST v1.1); or the first occurrence of progressive disease after 24 weeks of study treatment.
Time frame: Baseline and every 8 weeks from Cycle 1 Day 1 until Week 24 (each cycle is 28 days)
Duration of Response
DoR is defined as the percentage of participants achieving either of the following: confirmed complete response or partial response.
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Time frame: From the first occurrence of a documented objective response until first observation of disease progression or death from any cause on study, whichever occurs first (up to 24 months)