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NCT03724747 · ClinicalTrials.gov registry record · Phase 1
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, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT03724747: Completed Phase 1 study, sponsored by Bayer.
NCT03724747 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 63 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03724747, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study 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. 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.
Primary Outcome
The maximum dose at which the incidence of DLTs occurring during Cycle 1 is below 30%.
Interventions
- DRUG BAY2315497 Injection
- DRUG Darolutamide(BAY1841788)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2018-12-18 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 1 |
What the finished NCT03724747 record still lists
NCT03724747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which BAY2315497 Injection is the first listed.
NCT03724747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03724747 about?
NCT03724747 is a clinical study titled "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". 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 adminis...
What is the current status of trial NCT03724747?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2018-12-18. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT03724747?
The interventions under investigation include: BAY2315497 Injection (DRUG), Darolutamide(BAY1841788) (DRUG).
Who is sponsoring clinical trial NCT03724747?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03724747's enrollment target sits among peer trials
63 820th of 2000 higher than 1,177 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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