This clinical trial is evaluating a drug called AC682 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 AC682 that can be given safely to participants * To evaluate the side effects of AC682 * To evaluate pharmacokinetics of AC682 * To evaluate the effectiveness of AC682
This is a Phase I, first in human, open-label dose-escalation study of AC682, an orally available estrogen receptor degrader, given as a single agent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Participants will receive AC682 by mouth daily in 28-day cycles.
Site 01
Denver, Colorado, United States
Site 04
Orlando, Florida, United States
Site 02
Sarasota, Florida, United States
Site 03
Nashville, Tennessee, United States
Site 05
Incidence of dose limiting toxicities (DLTs)
Time frame: 28 days (Cycle 1)
Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682
Adverse events will be graded according to NCI CTCAE v5.0.
Time frame: Through study completion, approximately 18 months
Objective response rate (ORR) as a measure of anti-tumor activity
Time frame: Through study completion, approximately 18 months
Clinical benefit rate (CBR) as a measure of anti-tumor activity
Time frame: Through study completion, approximately 18 months
Duration of response (DOR) as a measure of anti-tumor activity
Time frame: Through study completion, approximately 18 months
Disease control rate (DCR) as a measure of anti-tumor activity
Time frame: Through study completion, approximately 18 months
Progression free survival (PFS) as a measure of anti-tumor activity
Time frame: Through study completion, approximately 18 months
Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))
Time frame: Through study completion, approximately 18 months
Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau))
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Houston, Texas, United States
Time frame: Through study completion, approximately 18 months
Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
Time frame: Through study completion, approximately 18 months
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
Time frame: Through study completion, approximately 18 months
Pharmacokinetic Analysis: terminal elimination half life (t1/2)
Time frame: Through study completion, approximately 18 months