Metastatic Castration Resistant Prostate Cancer (mCRPC)Phase 1NCT03724747
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
A Phase 1 study testing BAY2315497 Injection and Darolutamide(BAY1841788) in people with Metastatic Castration Resistant Prostate Cancer (mCRPC), run by Bayer at 5 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer (mCRPC)
- What is being tested?
- BAY2315497 Injection and Darolutamide(BAY1841788)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 18 Dec 2018to 31 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and sign an approved informed consent form.
- Male adult patients (≥ 18 years of age).
- ECOG PS of 0 or 1.
- Life expectancy ≥ 6 months.
- Histological, pathological and/or cytological confirmation of adenocarcinoma of the prostate without small cell or neuroendocrine features.
- Previous treatment with at least one novel androgen axis drug (NAAD) (e.g. enzalutamide and/or abiraterone).
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- Patients must have prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).
- Previous treatment with at least 1, but no more than 2 previous - taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, he is eligible, if refuses to receive a second taxane regimen, or is considered unsuitable to receive a second taxane regimen (e.g. intolerance).
- Documented progression of mCRPC, as defined according to the Prostate Cancer Working Group 3 (PCWG3) guidelines.
- Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements, to be conducted within 14 days before start of study drug administration:
- Hemoglobin > 9.0 g/dL
- Absolute neutrophil count (ANC) > 1500/mm3
- White blood cell (WBC) count > 3000/mL
- Platelet count > 100,000 /mm*3
- Total bilirubin < 1,5 x upper limit of normal (ULN) (except if confirmed history of Gilbert's disease)
- ALT and AST ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 X ULN and glomerular filtration rate (GFR ≥ 45 mL/min/1.73 m2, according to the MDRD (Modified Diet in Renal Disease) abbreviated formula.
- Patients with partners of childbearing potential must be willing to use highly effective methods of birth control for the time period between the first administration of BAY 2315497 Injection to at least 6 months after the last administration of the study drug.
- In the darolutamide BAY2315497 Injection combination escalation arm, patients at sites performing the PSMA and FDG PET/CTs should be able to tolerate the 3 radiotracer injections and the 3 whole body PET/CT scans.
Who cannot join
- Diffuse bone or bone-marrow involvement (i.e. "superscan").
- Spinal cord compression or known brain metastases.
- Known incompatibility to CT/MRI, bone scan or uncontrolled pain, which results in patient's lack of compliance with the CT/MRI and bone scan required for PCWG3 tumor assessment.
- Clinically significant heart disease, as evidenced by myocardial infarction, arterial thrombotic events in the past 6 months, severe or unstable angina, or uncontrolled cardiovascular history.
- Patients known to be affected by genetic defects linked to radiation Hypersensitivity.
- Known history of myelodysplastic syndrome (MDS) / leukemia or with features suggestive of MDS/AML at any time point.
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- Concurrent or active cancer within the last 2 years with a distinct primary site or histology from the cancer being evaluated in this study, with the exception of cancer types with less than 30% likelihood of recurrence.
- Known allergies, hypersensitivity, or intolerance to the study drug including excipients, or to contrast agents used in the diagnostic or exploratory imaging procedures required per protocol.
- Any infection of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Grade ≥ 2.
- Known human immunodeficiency virus (HIV) infection.
- Patients who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment.
- Serious, non-healing wound, ulcer, or bone fracture.
- Any systemic anti-neoplastic therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies], PARP inhibitors) within at least 30 days prior to day of randomization (except for Luteinizing Hormone-releasing Hormone [LHRH] or Gonadotropin-releasing Hormone [GnRH]).
- Previous high-dose chemotherapy, needing hemopoietic stem cell rescue, is prohibited.
- Prior major surgery (excluding prostatic biopsies) must be at least 12 weeks prior to study entry.
- Previous treatment with therapeutic PSMA-targeted agents.
- Previous treatment with radium-223 dichloride or other radiopharmaceuticals, including but not limited to strontium-89 or samarium-153.
- Prior definitive radiotherapy completed less than 6 weeks before start of the study drug administration
- Inability to swallow oral medications
- A gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of darolutamide
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Tulane Medical Center
New Orleans, Louisiana, 70112
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
GU Research Network, LLC
Omaha, Nebraska, 68130
United Kingdom1 site
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, SM2 5PT
About this study
Official title: 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
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.
- Being tested
- BAY2315497 Injection, Darolutamide(BAY1841788)
- Keywords
- Metastatic castration resistant prostate cancer, thorium-227, targeted alpha therapy,PSMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2315497 InjectionDrug
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.
Darolutamide(BAY1841788)Drug
600 mg (2 X 300 mg tablets), twice daily with food, equivalent to a total daily dose of 1200 mg.
| Study group | Role | What they receive |
|---|---|---|
| BAY2315497 dose escalation | Experimental | The thorium-227 dose will be escalated in a step-wise fashion to the MTD, according to a predefined dose escalation scheme. The total antibody dose of 50 mg will be evaluated first; on the basis of emerging clinical data, doses within the range of 20-100 mg may be investigated. Receives: Drug: BAY2315497 Injection |
| BAY2315497 dose escalation in combination with darolutamide | Experimental | The thorium-227 dose will be escalated in a step-wise fashion to the MTD, according to a predefined dose escalation scheme. In addition, Darolutamide oral dosing at the approved dose of twice daily 600 mg will be initiated 14 days prior to the first BAY2315497 Injection dose on Day 1 of the first cycle. Daily darolutamide dosing will continue throughout the entire BAY2315497 Injection treatment period until withdrawal criteria from study treatment period are met. Receives: Drug: BAY2315497 Injection; Drug: Darolutamide(BAY1841788) |
| BAY2315497 dose expansion:Dose regimen 1 | Experimental | The thorium-227 and total antibody doses, as well as the treatment regimen, will be selected for expansion on the basis of the safety, PK and overall benefit risk profile of BAY2315497 Injection, observed in the course of the dose escalation. Receives: Drug: BAY2315497 Injection |
| BAY2315497 dose expansion:Dose regimen 2 | Experimental | The thorium-227 and total antibody doses, as well as the treatment regimen, will be selected for expansion on the basis of the safety, PK and overall benefit risk profile of BAY2315497 Injection, observed in the course of the dose escalation. Receives: Drug: BAY2315497 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of BAY2315497 injection
The maximum dose at which the incidence of DLTs occurring during Cycle 1 is below 30%.
Measured: 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%.
Measured: Cycle 1 (42 days)
Secondary outcomes (14)
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.
Measured: 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
Measured: 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
Measured: Cycle 1 (From day 1 to 43)
Cmax of radium of BAY2315497 Injection
Measured: Cycle 1 (From day 1 to 43)
AUC(0-42) days of radium of BAY2315497 Injection
Measured: Cycle 1 (From day 1 to 43)
Cmax of total antibody of BAY2315497 Injection
Measured: Cycle 1 (From day 1 to 43)
AUC(0-42) days of total antibody of BAY2315497 Injection
Measured: 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.
Measured: 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
Measured: 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
Measured: Cycle 1 (From day 1 to 43)
Cmax of radium of BAY2315497 Injection in combination with darolutamide
Measured: Cycle 1 (From day 1 to 43)
AUC(0-42) days of radium of BAY2315497 Injection in combination with darolutamide
Measured: Cycle 1 (From day 1 to 43)
Cmax of total antibody of BAY2315497 Injection in combination with darolutamide
Measured: Cycle 1 (From day 1 to 43)
AUC(0-42) days of total antibody of BAY2315497 Injection in combination with darolutamide
Measured: Cycle 1 (From day 1 to 43)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start18 Dec 2018
- Primary completion25 Aug 2022
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724747
- Sponsor's protocol ID
- 19445
- Other IDs
- 2018-001490-25, 2018
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2018
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Hammer S, Hagemann UB, Zitzmann-Kolbe S, Larsen A, Ellingsen C, Geraudie S, Grant D, Indrevoll B, Smeets R, von Ahsen O, Kristian A, Lejeune P, Hennekes H, Karlsson J, Bjerke RM, Ryan OB, Cuthbertson AS, Mumberg D. Preclinical Efficacy of a PSMA-Targeted Thorium-227 Conjugate (PSMA-TTC), a Targeted Alpha Therapy for Prostate Cancer. Clin Cancer Res. 2020 Apr 15;26(8):1985-1996. doi: 10.1158/1078-0432.CCR-19-2268. Epub 2019 Dec 12.
PubMed 31831560
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03724747
- Acronym / sponsor ID
- 19445
- Keywords
- Metastatic castration resistant prostate cancer, thorium-227, targeted alpha therapy,PSMA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BAY2315497 dose escalation | Experimental | Drug: BAY2315497 InjectionThe thorium-227 dose will be escalated in a step-wise fashion to the MTD, according to a predefined dose escalation scheme. The total antibody dose of 50 mg will be evaluated first; on the basis of emerging clinical data, doses within the range of 20-100 mg may be investigated. |
| BAY2315497 dose escalation in combination with darolutamide | Experimental | Drug: BAY2315497 Injection, Drug: Darolutamide(BAY1841788)The thorium-227 dose will be escalated in a step-wise fashion to the MTD, according to a predefined dose escalation scheme. In addition, Darolutamide oral dosing at the approved dose of twice daily 600 mg will be initiated 14 days prior to the first BAY2315497 Injection dose on Day 1 of the first cycle. Daily darolutamide dosing will continue throughout the entire BAY2315497 Injection treatment period until withdrawal criteria from study treatment period are met. |
| BAY2315497 dose expansion:Dose regimen 1 | Experimental | Drug: BAY2315497 InjectionThe thorium-227 and total antibody doses, as well as the treatment regimen, will be selected for expansion on the basis of the safety, PK and overall benefit risk profile of BAY2315497 Injection, observed in the course of the dose escalation. |
| BAY2315497 dose expansion:Dose regimen 2 | Experimental | Drug: BAY2315497 InjectionThe thorium-227 and total antibody doses, as well as the treatment regimen, will be selected for expansion on the basis of the safety, PK and overall benefit risk profile of BAY2315497 Injection, observed in the course of the dose escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Ability to understand and sign an approved informed consent form.
- Male adult patients (≥ 18 years of age).
- ECOG PS of 0 or 1.
- Life expectancy ≥ 6 months.
- Histological, pathological and/or cytological confirmation of adenocarcinoma of the prostate without small cell or neuroendocrine features.
Key exclusion criteria (20 listed)
- Diffuse bone or bone-marrow involvement (i.e. "superscan").
- Spinal cord compression or known brain metastases.
- Known incompatibility to CT/MRI, bone scan or uncontrolled pain, which results in patient's lack of compliance with the CT/MRI and bone scan required for PCWG3 tumor assessment.
- Clinically significant heart disease, as evidenced by myocardial infarction, arterial thrombotic events in the past 6 months, severe or unstable angina, or uncontrolled cardiovascular history.
- Patients known to be affected by genetic defects linked to radiation Hypersensitivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY2315497 InjectionBAY 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. | Drug | BAY2315497 dose escalation, BAY2315497 dose escalation in combination with darolutamide, BAY2315497 dose expansion:Dose regimen 1, BAY2315497 dose expansion:Dose regimen 2 |
| Darolutamide(BAY1841788)600 mg (2 X 300 mg tablets), twice daily with food, equivalent to a total daily dose of 1200 mg. | Drug | BAY2315497 dose escalation in combination with darolutamide |
Primary outcome
Maximum tolerated dose (MTD) of BAY2315497 injection
Time frame: Cycle 1 (42 days)
The maximum dose at which the incidence of DLTs occurring during Cycle 1 is below 30%.
Maximum tolerated dose (MTD) of BAY2315497 injection in combination with darolutamide
Time frame: Cycle 1 (42 days)
The maximum dose at which the incidence of DLTs occurring during Cycle 1 is below 30%.
14 secondary outcomes
Recommended dose for further clinical development of BAY2315497 injection
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Derived from this study: PubMed 31831560Hammer S, Hagemann UB, Zitzmann-Kolbe S, Larsen A, Ellingsen C, Geraudie S, Grant D, Indrevoll B, Smeets R, von Ahsen O, Kristian A, Lejeune P, Hennekes H, Karlsson J, Bjerke RM, Ryan OB, Cuthbertson AS, Mumberg D. Preclinical Efficacy of a PSMA-Targeted Thorium-227 Conjugate (PSMA-TTC), a Targeted Alpha Therapy for Prostate Cancer. Clin Cancer Res. 2020 Apr 15;26(8):1985-1996. doi: 10.1158/1078-0432.CCR-19-2268. Epub 2019 Dec 12.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2315497 Injection and Darolutamide(BAY1841788) in people with Metastatic Castration Resistant Prostate Cancer (mCRPC), run by Bayer at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Finland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of BAY2315497 injection (time frame: Cycle 1 (42 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.