This clinical trial is evaluating a drug called AC176 in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed on at least one prior systemic therapy. The main goals of this study are to: Evaluate the safety and tolerability of AC176, evaluate pharmacokinetics and preliminary antitumor activity of AC176
AC176-002 is a Phase I, open-label, multi-center dose-escalation study of AC176 given orally 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 patients with metastatic castration resistant prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
AC176 will be given orally (PO) on a 28-day cycle.
Site 2001
Beijing, China
Site 2003
Guangzhou, China
Site 2004
Hunan, China
Site 2005
Nanchang, China
Site 2002
Shanghai, China
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
Clinically significant abnormalities in vital signs
Vital signs abnormalities as characterized by type, frequency, severity and timing;
Time frame: Through study completion, approximately 24 months
Clinically significant abnormalities in laboratory tests
Laboratory abnormalities as characterized by type, frequency, severity and timing;
Time frame: Through study completion, approximately 24 months
Clinically significant abnormalities in electrocardiogram (ECG)
Electrocardiogram (ECG) abnormalities such as QTcF, PR, RR and QRS intervals
Time frame: Through study completion, approximately 24 months
Clinically significant abnormalities in heart rate
Time frame: Through study completion, approximately 24 months
Prostate-specific antigen (PSA) response rates based on Prostate Cancer Working Group 3 (PCWG3) criteria.
PSA response rate per PCWG3
Time frame: Throughout the study, approximately 24 months
Objective Response Rate(ORR)
Time frame: Throughout the study, approximately 24 months
Radiographic progression-free survival (rPFS)
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Time frame: Throughout the study, approximately 24 months
Time to progression (TTP)
Time frame: Throughout the study, approximately 24 months
Duration of response (DoR)
Time frame: Throughout the study, approximately 24 months
Progression-free survival (PFS)
Time frame: Throughout the study, approximately 24 months
Pharmacokinetic Analysis
Area under the concentration-time curve over the dosing interval (AUC(0-tau))
Time frame: 24 weeks
Pharmacokinetic Analysis
Maximum plasma concentration (Cmax)
Time frame: 24 weeks
Pharmacokinetic Analysis
Terminal elimination half life (t1/2)
Time frame: 24 weeks