Terminated/Withdrawn
Sponsor ID
20180101

Safety, Tolerability, Pharmacokinetics, and Efficacy of acapatamab in Subjects with mCRPC

Sponsor ID
20180101
Clinicaltrials.gov ID
NCT03792841
EUCTIS ID
N/A
EudraCT ID
N/A

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).

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
212
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Scientia Clinical Research Ltd
Randwick, NSW, Australia, 2031
Status
Recruiting
Location
Peter MacCallum Cancer Centre
Parkville, VIC, Australia, 3050
Status
Recruiting
Location
Chris OBrien Lifehouse
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
Landeskrankenhaus Salzburg
Salzburg, Austria, 5020
Status
Recruiting
Location
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Bruxelles, Belgium, 1200
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
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