This clinical trial is evaluating a drug called AC176 in participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed on at least two prior systemic therapies. The main goals of this study are to: * Identify the recommended dose of AC176 that can be given safely to participants * Evaluate the side effects of AC176 * Evaluate pharmacokinetics of AC176 * Evaluate the effectiveness of AC176
AC176-001 is a Phase I, first-in-human, open-label, multi-center dose-escalation study of AC176 given as a single agent. The AC176 is an investigational medicinal product that is a potent orally bioavailable Androgen Receptor (AR) degrader studied for the treatment of Metastatic Castration Resistant Prostate Cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
AC176 will be given orally (PO) on a 28-day cycle.
Site 02
Denver, Colorado, United States
Site 03
Sarasota, Florida, United States
Site 05
Detroit, Michigan, United States
Site 01
Nashville, Tennessee, United States
Site 04
Incidence of dose limiting toxicities (DLTs) from AC176 monotherapy
Number of subjects with DLT
Time frame: 28 days
Adverse events (AEs)/Serious adverse events (SAEs)
Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC176
Time frame: Through study completion, approximately 24 months
Number of patients with vital signs abnormalities
Vital signs abnormalities as characterized by type, frequency, severity and timing
Time frame: Through study completion, approximately 24 months
Incidence of laboratory abnormalities as a measure of safety and tolerability of AC176
Laboratory abnormalities as characterized by type, frequency, severity and timing
Time frame: Through study completion, approximately 24 months
Incidence of Electrocardiogram (ECG) abnormalities as a measure of safety and tolerability of AC176
Electrocardiogram (ECG) abnormalities such as heart rate, QTcF, PR, RR and QRS intervals
Time frame: Through study completion, approximately 24 months
Prostate-Specific Antigen (PSA) response rate
PSA response rate per PCWG3
Time frame: Throughout the study, approximately 24 months
Title: Duration of Response (DoR)
Time frame: Throughout the study, approximately 24 months
Objective Response Rate(ORR)
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Dallas, Texas, United States
Time frame: Throughout the study, approximately 24 months
Time-to-Progression (TTP)
Time frame: Throughout the study, approximately 24 months
Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))
Time frame: 20 weeks
Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau))
Time frame: 20 weeks
Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
Time frame: 20 weeks
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
Time frame: 20 weeks
Pharmacokinetic Analysis: terminal elimination half life (t1/2)
Time frame: 20 weeks