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Also known as BAY2315497 Injection
BAY2315497 · 1 trial · 1 indication
The maximum dose at which the incidence of DLTs occurring during Cycle 1 is below 30%.
The maximum dose at which the incidence of DLTs occurring during Cycle 1 is below 30%.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| BAY2315497 Injection | DRUG | 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. |
Inclusion Criteria * 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 n...
BAY2315497 is an investigational small molecule developed by Bayer AG for metastatic castration resistant prostate cancer (mCRPC). It is a thorium-227 labeled antibody-chelator conjugate that has been studied both alone and in combination with darolutamide. It is in Phase 1 clinical development and is not approved for any indication.
BAY2315497 is being studied for the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult male patients. The Phase 1 trial evaluated it alone and in combination with darolutamide. It is investigational and has not been approved for the treatment of mCRPC or any other condition.
BAY2315497 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 1 study of the thorium-227 labeled antibody-chelator conjugate in metastatic castration resistant prostate cancer. No other developer or partnership for this asset has been disclosed.
BAY2315497 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not received FDA approval for metastatic castration resistant prostate cancer or any other indication.
BAY2315497 was evaluated in one Phase 1 trial, NCT03724747, titled a study of a thorium-227 labeled antibody-chelator conjugate alone and in combination with darolutamide in patients with metastatic castration resistant prostate cancer. The trial enrolled 63 patients across the United States, Finland, and the United Kingdom and is completed.
Yes. BAY2315497 Injection is an alternative name for BAY2315497, the Bayer AG thorium-227 labeled antibody-chelator conjugate being studied in metastatic castration resistant prostate cancer. Both names refer to the same investigational small molecule asset in Phase 1 development.