This study will treat patients with Metastatic Castration Resistant Prostate Cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
A first-time-in-human, Phase I, open-label, multicenter study to determine safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of DZD2269 in patients with mCRPC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
A single dose of DZD2269 starting at 5 mg will be given on Cycle 0 and then followed by a wash-out period. Multiple doses of DZD2269 at the same dose level will be given once daily after the wash-out period.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Incidence of AEs and SAEs
To investigate the safety and tolerability of DZD2269 as monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC)
Time frame: From screening to 28 days after the last dose
Incidence of DLTs
To establish Maximum Tolerated Dose (MTD) (if possible) in patients with mCRPC
Time frame: From the first dose of study treatment up to the last day of Cycle 1 (28 days after start of multiple dosing)
Drug concentrations of DZD2269 in plasma and urine
Pharmacokinetics endpoints
Time frame: to approximately 6 months
Maximum plasma concentration (Cmax) of DZD2269
Pharmacokinetics endpoints
Time frame: up to approximately 6 months
Area under the plasma concentration-time curve (AUC) of DZD2269
Pharmacokinetics endpoints
Time frame: up to approximately 6 months
Objective Response Rate (ORR)
To assess the preliminary anti-tumor efficacy of DZD2269 as monotherapy based on modified RECIST
Time frame: Through the study completion, an average of around 1 year
Disease Control Rate (DCR);
To assess the preliminary anti-tumor efficacy of DZD2269 as monotherapy based on modified RECIST
Time frame: Through the study completion, an average of around 1 year
Duration of Response (DoR)
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Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea - Seoul St. Marys Hospital
Seoul, South Korea
To assess the preliminary anti-tumor efficacy of DZD2269 as monotherapy based on modified RECIST
Time frame: Through the study completion, an average of around 1 year