Your session is about to expire
← Back to Search
Monoclonal Antibodies
Thorium-227 Conjugate + Darolutamide for Prostate Cancer
Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented progression of mCRPC, as defined according to the Prostate Cancer Working Group 3 (PCWG3) guidelines
Male adult patients (≥ 18 years of age)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
Study Summary
This trial is studying an investigational medication called BAY 2315497 Injection to see if it is safe and effective in treating patients with metastatic castration resistant prostate cancer.
Who is the study for?
This trial is for adult males with advanced prostate cancer that has resisted castration treatment and progressed despite hormone therapy. Participants must have had prior treatments, be in good physical condition (ECOG PS of 0 or 1), and expect to live at least another six months. They should not have other active cancers or serious heart conditions, infections, or immune deficiencies.Check my eligibility
What is being tested?
The study tests a new drug called BAY2315497 Injection targeting prostate cancer cells, alone or with Darolutamide. It aims to find the safest dose with tolerable side effects (Maximal Tolerated Dose) and how the body processes these drugs.See study design
What are the potential side effects?
Potential side effects may include reactions related to radiation exposure since BAY2315497 includes thorium-227. Other risks could involve typical chemotherapy-related issues like fatigue, nausea, blood cell count changes, and increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer has worsened despite treatment.
Select...
I am a man aged 18 or older.
Select...
I am fully active or can carry out light work.
Select...
I have been treated with a drug like enzalutamide or abiraterone.
Select...
My prostate cancer is confirmed without specific aggressive features.
Select...
I have undergone orchiectomy or am on androgen deprivation therapy with low testosterone levels.
Select...
My blood, liver, and kidney tests meet the required levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of BAY2315497 injection
Maximum tolerated dose (MTD) of BAY2315497 injection in combination with darolutamide
Secondary outcome measures
AUC(0-42) days of radium of BAY2315497 Injection
AUC(0-42) days of radium of BAY2315497 Injection in combination with darolutamide
AUC(0-42) days of total antibody of BAY2315497 Injection
+11 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: BAY2315497 dose expansion:Dose regimen 2Experimental Treatment1 Intervention
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.
Group II: BAY2315497 dose expansion:Dose regimen 1Experimental Treatment1 Intervention
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.
Group III: BAY2315497 dose escalation in combination with darolutamideExperimental Treatment2 Interventions
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.
Group IV: BAY2315497 dose escalationExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,915 Total Patients Enrolled
39 Trials studying Prostate Cancer
25,919 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer has worsened despite treatment.I can undergo 3 radiotracer injections and 3 whole body PET/CT scans.I have not had high-dose chemotherapy requiring stem cell support.I am HIV positive.I am fully active or can carry out light work.I have a history of or signs suggesting myelodysplastic syndrome or leukemia.I am not allergic to the study drug or any imaging contrast agents.I have a stomach or intestine condition that affects how my body absorbs medicine.I am currently being treated for active hepatitis B or C.I have a serious heart condition.I do not have a serious infection.My last major surgery was over 12 weeks ago.I am a man aged 18 or older.I have a serious wound or broken bone that is not healing.I have been treated with radium-223 or similar radioactive drugs.I finished my radiotherapy less than 6 weeks ago.I have been treated with PSMA-targeted therapy before.I have been treated with a drug like enzalutamide or abiraterone.I cannot swallow pills.I have had 1 or 2 treatments with taxane, or cannot have more due to intolerance.I do not have spinal cord compression or brain metastases.My prostate cancer is confirmed without specific aggressive features.I haven't had cancer treatment in the last 30 days.I have undergone orchiectomy or am on androgen deprivation therapy with low testosterone levels.I haven't had a different cancer in the last 2 years.My cancer has spread extensively to my bones or bone marrow.I am sensitive to radiation due to my genetics.My blood, liver, and kidney tests meet the required levels.
Research Study Groups:
This trial has the following groups:- Group 1: BAY2315497 dose expansion:Dose regimen 2
- Group 2: BAY2315497 dose escalation
- Group 3: BAY2315497 dose escalation in combination with darolutamide
- Group 4: BAY2315497 dose expansion:Dose regimen 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What past experiments have showcased the efficacy of BAY2315497 Injection?
"Currently, there are 24 ongoing clinical trials evaluating BAY2315497 Injection. Of those studies 9 have advanced to Phase 3 of the trial process. Most locations for these experiments are in Toronto, Ontario, however 1436 sites worldwide offer this treatment."
Answered by AI
Is this experiment currently enrolling participants?
"Based on the information available, this clinical trial is not actively enrolling new participants. The study was initially posted in December 2018 and last updated in November 2022. Nevertheless, there are over 1200 other trials that are currently open for recruitment of patients."
Answered by AI
Has the FDA sanctioned BAY2315497 Injection for use?
"As BAY2315497 Injection is currently in its first phase of testing, there isn't much data available to assess safety and efficacy. We have thus rated this drug's safety as a 1 on our scale."
Answered by AI
How many participants are actively engaged in this clinical investigation?
"At this time, the clinical trial is not actively admitting patients. It was initially posted on December 18th 2018 and last updated on November 20th 2022. However, if you are searching for other trials there are 1257 studies recruiting participants with prostate cancer and 24 examining the effects of BAY2315497 Injection."
Answered by AI
Does this research innovate upon any prior studies?
"Ever since 2016, BAY2315497 Injection has undergone extensive research. The first study was organized by Orion Corporation and had 1303 participants. Afterward, the drug received its Phase 3 approval from regulatory bodies before being assessed in 24 clinical trials across 44 nations and 557 cities worldwide."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger