check_circleStudy Completed
Metastatic castration resistant prostate cancer (mCRPC)
Bayer Identifier:
19445
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to evaluate the safety, tolerability,pharmacokinetics, and antitumor activity of a thorium-227 labeled antibody-chelator conjugate alone and in combination with darolutamide, in patients with metastatic castration resistant prostate cancer
Trial purpose
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.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
63Trial Dates
December 2018 - October 2024Phase
Phase 1Could I Receive a placebo
NoProducts
BAY2315497Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Completed | HUS, Meilahden sairaala | Helsinki, FIN-00260, Finland |
Withdrawn | Skånes Universitetssjukhus | Lund, 221 85, Sweden |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10065, United States |
Completed | Tulane Medical Center | New Orleans, 70112, United States |
Completed | GU Research Network, LLC | Omaha, 68130, United States |
Withdrawn | Washington University School of Medicine | St. Louis, 63110, United States |
Withdrawn | Klinikum rechts der Isar | München, 81675, Germany |
Withdrawn | Erasmus Medisch Centrum | ROTTERDAM, 3015 CE, Netherlands |
Primary Outcome
- Maximum tolerated dose (MTD) of BAY2315497 injectionThe maximum dose at which the incidence of DLTs occurring during Cycle 1 is below 30%.date_rangeTime Frame:Cycle 1 (42 days)
- Maximum tolerated dose (MTD) of BAY2315497 injection in combination with darolutamideThe maximum dose at which the incidence of DLTs occurring during Cycle 1 is below 30%.date_rangeTime Frame:Cycle 1 (42 days)
Secondary Outcome
- Recommended dose for further clinical development of BAY2315497 injectionThe 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.date_rangeTime 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 Injectiondate_rangeTime 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 Injectiondate_rangeTime Frame:Cycle 1 (From day 1 to 43)
- Cmax of radium of BAY2315497 Injectiondate_rangeTime Frame:Cycle 1 (From day 1 to 43)
- AUC(0-42) days of radium of BAY2315497 Injectiondate_rangeTime Frame:Cycle 1 (From day 1 to 43)
- Cmax of total antibody of BAY2315497 Injectiondate_rangeTime Frame:Cycle 1 (From day 1 to 43)
- AUC(0-42) days of total antibody of BAY2315497 Injectiondate_rangeTime Frame:Cycle 1 (From day 1 to 43)
- Recommended dose for further clinical development of BAY2315497 injection in combination with darolutamideThe 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.date_rangeTime 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 darolutamidedate_rangeTime 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 darolutamidedate_rangeTime Frame:Cycle 1 (From day 1 to 43)
- Cmax of radium of BAY2315497 Injection in combination with darolutamidedate_rangeTime Frame:Cycle 1 (From day 1 to 43)
- AUC(0-42) days of radium of BAY2315497 Injection in combination with darolutamidedate_rangeTime Frame:Cycle 1 (From day 1 to 43)
- Cmax of total antibody of BAY2315497 Injection in combination with darolutamidedate_rangeTime Frame:Cycle 1 (From day 1 to 43)
- AUC(0-42) days of total antibody of BAY2315497 Injection in combination with darolutamidedate_rangeTime Frame:Cycle 1 (From day 1 to 43)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
4