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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 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 63 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03724747
The ClinicalTrials.gov registry entry for NCT03724747 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BAY2315497 Injection is the first listed.
NCT03724747 reports 0 study locations.
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.
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