The study medication (BAY 2315497 Injection) is a thorium-227 labeled immuno-conjugate, specific for the prostate-specific membrane antigen (PSMA), which will be evaluated in patients with metastatic castration resistant prostate cancer. In this study, this investigational medication will be administered to patients for the first time. The primary objective of the study is to define the safety and tolerability profile and Maximal Tolerated Dose (MTD) of BAY2315497 Injection alone, or in combination with darolutamide. The secondary objectives are to determine the recommended dose for further clinical development of BAY2315497 Injection alone, or in combination with darolutamide and to investigate how the study drug is distributed and cleared from the body.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
BAY 2315497 Injection comprises 3 components: the PSMA-specific monoclonal antibody (mAb), the mAb-chelator conjugate, and the thorium-227 labeled mAb-chelator conjugate. BAY 2315497 Injection will be administered on Day 1 of each treatment cycle.
600 mg (2 X 300 mg tablets), twice daily with food, equivalent to a total daily dose of 1200 mg.
Tulane Medical Center
New Orleans, Louisiana, United States
GU Research Network, LLC
Omaha, Nebraska, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
HUS, Meilahden sairaala
Helsinki, Finland
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, United Kingdom
Maximum tolerated dose (MTD) of BAY2315497 injection
The maximum dose at which the incidence of DLTs occurring during Cycle 1 is below 30%.
Time frame: Cycle 1 (42 days)
Maximum tolerated dose (MTD) of BAY2315497 injection in combination with darolutamide
The maximum dose at which the incidence of DLTs occurring during Cycle 1 is below 30%.
Time frame: Cycle 1 (42 days)
Recommended dose for further clinical development of BAY2315497 injection
The dose / regimen recommended for further clinical development will be defined after evaluation of the safety, PK and overall clinical data, collected in cycle 1 and subsequent cycles, in the dose escalation and dose expansion parts of the study.
Time frame: Up to 6 cycles (each cycle is 42 days, a maximum of 3 additional treatment cycles may be administered in case a favorable benefit risk profile is documented)
Maximum observed concentration (Cmax) of thorium of BAY2315497 Injection
Time frame: Cycle 1 (From day 1 to 43)
Area under the curve from time of dosing to 42 days after dosing [AUC(0-42)] days of thorium of BAY2315497 Injection
Time frame: Cycle 1 (From day 1 to 43)
Cmax of radium of BAY2315497 Injection
Time frame: Cycle 1 (From day 1 to 43)
AUC(0-42) days of radium of BAY2315497 Injection
Time frame: Cycle 1 (From day 1 to 43)
Cmax of total antibody of BAY2315497 Injection
Time frame: Cycle 1 (From day 1 to 43)
AUC(0-42) days of total antibody of BAY2315497 Injection
Time frame: Cycle 1 (From day 1 to 43)
Recommended dose for further clinical development of BAY2315497 injection in combination with darolutamide
The dose / regimen recommended for further clinical development will be defined after evaluation of the safety, PK and overall clinical data, collected in cycle 1 and subsequent cycles, in the dose escalation and dose expansion parts of the study.
Time frame: Up to 6 cycles (each cycle is 42 days, a maximum of 3 additional treatment cycles may be administered in case a favorable benefit risk profile is documented)
Maximum observed concentration (Cmax) of thorium of BAY2315497 Injection in combination with darolutamide
Time frame: Cycle 1 (From day 1 to 43)
Area under the curve from time of dosing to 42 days after dosing [AUC(0-42)] days of thorium of BAY2315497 Injection in combination with darolutamide
Time frame: Cycle 1 (From day 1 to 43)
Cmax of radium of BAY2315497 Injection in combination with darolutamide
Time frame: Cycle 1 (From day 1 to 43)
AUC(0-42) days of radium of BAY2315497 Injection in combination with darolutamide
Time frame: Cycle 1 (From day 1 to 43)
Cmax of total antibody of BAY2315497 Injection in combination with darolutamide
Time frame: Cycle 1 (From day 1 to 43)
AUC(0-42) days of total antibody of BAY2315497 Injection in combination with darolutamide
Time frame: Cycle 1 (From day 1 to 43)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.