This clinical trial is evaluating a drug called AC699 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to: * Identify the recommended dose of AC699 that can be given safely to participants * Evaluate the safety profile of AC699 * Evaluate the pharmacokinetics of AC699 * Evaluate the effectiveness of AC699
This study is a Phase I, first-in-human, open-label dose-escalation study of AC699, an orally bioavailable estrogen receptor degrader, given as a single agent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Participants will receive AC699 orally daily in 28-day cycles.
Site 08
Denver, Colorado, United States
Site 07
Orlando, Florida, United States
Site 02
Sarasota, Florida, United States
Site 06
Rockville, Maryland, United States
Site 01
Nashville, Tennessee, United States
Site 03
Houston, Texas, United States
Site 09
San Antonio, Texas, United States
Site 05
Norfolk, Virginia, United States
Site 04
Vancouver, Washington, United States
Incidence of dose limiting toxicities (DLTs) from AC699 monotherapy
Time frame: First 28 days of treatment. Cycles are 28 days.
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher lab abnormalities following administration of AC699
Time frame: Approximately 18 months.
Objective response rate (ORR) to assess the anti-tumor activity of AC699
Time frame: Approximately 18 months.
Clinical Benefit Rate (CBR) to assess the anti-tumor activity of AC699 using RECIST 1.1
Time frame: Approximately 18 months.
Duration of Response (DOR) to assess the anti-tumor activity of AC699 using RECIST 1.1
Time frame: Approximately 18 months.
Disease Control Rate (DCR) to assess the anti-tumor activity of AC699 using RECIST 1.1
Time frame: Approximately 18 months.
Progression Free Survival (PFS) to assess the anti-tumor activity of AC699 using RECIST 1.1
Time frame: Approximately 18 months.
Pharmacokinetic Analysis: Area under the concentration-time curve over the dosing interval (AUC(0-infinity))
Time frame: Up to approximately 28 weeks
Pharmacokinetic Analysis: Area under the concentration-time curve over the dosing interval (AUC(0-tau))
Time frame: Up to approximately 28 weeks
Pharmacokinetic Analysis: Maximum plasma concentration (Cmax)
Time frame: Up to approximately 28 weeks
Pharmacokinetic Analysis: Time to maximum plasma concentration (tmax)
Time frame: Up to approximately 28 weeks
Pharmacokinetic Analysis: Terminal elimination half-life (t1/2)
Time frame: Up to approximately 28 weeks
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