Safety, Tolerability, Pharmacokinetics, and Efficacy of acapatamab in Subjects with mCRPC
Study Details
A phase 1 study evaluating the safety, tolerability, pharmacokinetics, and efficacy of prostate specific membrane antigen half-life extended bispecific T-cell engager acapatamab in subjects with metastatic castration-resistant prostate cancer, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
Protocol Summary
Number of participants with dose-limiting toxicity
Timeframe: Up to 3 years
Number of participants with treatment-emergent adverse events
Timeframe: Up to 3 years
Number of participants with treatment-related adverse events
Timeframe: Up to 3 years
Number of participants with clinically significant changes in vital signs
Timeframe: Up to 3 years
Number of participants with clinically significant changes in electrocardiogram (ECG)
Timeframe: Up to 3 years
Number of participants with clinically significant changes in clinical laboratory tests
Timeframe: Up to 3 years
Maximum serum concentration (Cmax) of acapatamab
Timeframe: Up to 3 years
Minimum serum concentration (Cmin) of acapatamab
Timeframe: Up to 3 years
Area under the concentration-time curve (AUC) over the dosing interval of acapatamab
Timeframe: Up to 3 years
Accumulation ratio of acapatamab
Timeframe: Up to 3 years
Half-life of acapatamab
Timeframe: Up to 3 years
Objective response (OR)
Timeframe: Up to 3 years
Prostate-specific antigen (PSA) response
Timeframe: Up to 3 years
Duration of response (DOR) (radiographic and PSA)
Timeframe: Up to 3 years
Percentage of participants experiencing a response based on 68Gallium (68Ga)-prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) response evaluations
Timeframe: Up to 3 years
Percentage of participants experiencing a response based on 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) response evaluations
Timeframe: Up to 3 years
Change in time to progression (radiographic and PSA)
Timeframe: Up to 3 years
Progression-free survival (PFS) (radiographic and PSA)
Timeframe: Up to 3 years
1, 2 and 3-year overall survival (OS)
Timeframe: Up to 3 years
Percentage of participants experiencing circulating tumor cells (CTC) response
Timeframe: Up to 3 years
Other PCWG3-recommended endpoints - time to symptomatic skeletal events
Timeframe: Up to 3 years
Other PCWG3-recommended endpoints - lactate dehydrogenase [LDH] levels
Timeframe: Up to 3 years
Other PCWG3-recommended endpoints - hemoglobin levels
Timeframe: Up to 3 years
Other PCWG3-recommended endpoints - neutrophil-to-lymphocyte ratio
Timeframe: Up to 3 years
Other PCWG3-recommended endpoints - urine N-telopeptide levels
Timeframe: Up to 3 years
Other PCWG3-recommended endpoints - alkaline phosphatase [total, bone] levels
Timeframe: Up to 3 years
Maximum serum concentration (Cmax) of acapatamab when administered with CYP enzymes
Timeframe: Up to 3 years
Area under the concentration-time curve over a 24-hour period (AUC24) of acapatamab when administered with CYP enzymes
Timeframe: Up to 3 years
Half-life of acapatamab when administered with CYP enzymes
Timeframe: Up to 3 years