This clinical trial is evaluating 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: 1. To evaluate the safety and tolerability of AC682 2. To evaluate the pharmacokinetic of AC682 3. To evaluate the preliminary anti-tumor activity of AC682
This is a Phase I, 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
6
Participants will receive AC682 by mouth daily in 28-day cycles.
Site 1001
Beijing, China
Site 1003
Hangzhou, China
Site 1002
Tianjin, China
Incidence of dose limiting toxicities (DLTs) from AC682 monotherapy
Number of subjects with DLT
Time frame: 28 days
Incidence of treatment emergent adverse events(TEAEs) from AC682 monotherapy
Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC682
Time frame: Throughout the study completion, approximately 24 months
To determine the PK of AC682 after a single dose or multiple doses:
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))
Time frame: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Area under the concentration-time curve over the dosing interval (AUC(0-tau))
Time frame: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Maximum plasma concentration (Cmax)
Time frame: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Time to maximum plasma concentration (tmax)
Time frame: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Terminal elimination half life (t1/2)
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Time frame: At predefined intervals throughout the study completion, approximately 24 months.
To evaluate the preliminary anti-tumor activity of AC682:
Objective Response Rate(ORR) using RECIST version 1.1
Time frame: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Clinical Benefit Rate (CBR) using RECIST version 1.1
Time frame: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Duration of Response (DoR) using RECIST version 1.1
Time frame: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Disease Control Rate (DCR) using RECIST version 1.1
Time frame: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Progression-free Survival (PFS) using RECIST version 1.1
Time frame: Throughout the study completion, approximately 24 months