check_circleStudy Completed
Metastatic castration resistant prostate cancer (mCRPC)
Bayer Identifier:infoA unique number for a trial given by Bayer.
19445
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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 info
63The overall number of participants needed for a trial.
Trial Dates info
December 2018 - October 2024Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 1A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
BAY2315497A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where 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 OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 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 OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- 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 info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
Non-randomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Sequential AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
4A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.