check_circleStudy Completed

Metastatic castration resistant prostate cancer (mCRPC)

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

Male

Age

18 - N/A

Trial summary

Enrollment Goal
63
Trial Dates
December 2018 - October 2024
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY2315497
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
HUS, Meilahden sairaalaHelsinki, FIN-00260, Finland
Withdrawn
Skånes UniversitetssjukhusLund, 221 85, Sweden
Completed
Memorial Sloan-Kettering Cancer CenterNew York, 10065, United States
Completed
Tulane Medical CenterNew Orleans, 70112, United States
Completed
GU Research Network, LLCOmaha, 68130, United States
Withdrawn
Washington University School of MedicineSt. Louis, 63110, United States
Withdrawn
Klinikum rechts der IsarMünchen, 81675, Germany
Withdrawn
Erasmus Medisch CentrumROTTERDAM, 3015 CE, Netherlands

Primary Outcome

  • Maximum tolerated dose (MTD) of BAY2315497 injection
    The 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 darolutamide
    The 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 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.
    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
    date_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
    date_rangeTime Frame:
    Cycle 1 (From day 1 to 43)
  • Cmax of radium of BAY2315497 Injection
    date_rangeTime Frame:
    Cycle 1 (From day 1 to 43)
  • AUC(0-42) days of radium of BAY2315497 Injection
    date_rangeTime Frame:
    Cycle 1 (From day 1 to 43)
  • Cmax of total antibody of BAY2315497 Injection
    date_rangeTime Frame:
    Cycle 1 (From day 1 to 43)
  • AUC(0-42) days of total antibody of BAY2315497 Injection
    date_rangeTime 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.
    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 darolutamide
    date_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 darolutamide
    date_rangeTime Frame:
    Cycle 1 (From day 1 to 43)
  • Cmax of radium of BAY2315497 Injection in combination with darolutamide
    date_rangeTime Frame:
    Cycle 1 (From day 1 to 43)
  • AUC(0-42) days of radium of BAY2315497 Injection in combination with darolutamide
    date_rangeTime Frame:
    Cycle 1 (From day 1 to 43)
  • Cmax of total antibody of BAY2315497 Injection in combination with darolutamide
    date_rangeTime Frame:
    Cycle 1 (From day 1 to 43)
  • AUC(0-42) days of total antibody of BAY2315497 Injection in combination with darolutamide
    date_rangeTime Frame:
    Cycle 1 (From day 1 to 43)

Trial design

A Phase 1, open-label, first-in-human, multi-center, study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of a thorium-227 labeled antibody-chelator conjugate, BAY 2315497 Injection alone, and in combination with darolutamide (BAY 1841788), in patients with metastatic castration resistant prostate cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
4