Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of metastatic castration resistant prostate cancer (mCRPC). It is currently in Phase 1 clinical development and is not approved by regulatory authorities.
BAY2315497 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY.
BAY2315497 is in Phase 1 clinical development. A Phase 1 study evaluating the drug has been completed, but the drug remains investigational and has not received regulatory approval.
BAY2315497 has been studied in one completed Phase 1 clinical trial, identified as NCT03724747. The trial evaluated the safety, tolerability, pharmacokinetics, and antitumor activity of the drug in patients with metastatic castration resistant prostate cancer.
BAY2315497 is the drug being evaluated in a clinical trial that also tests a thorium-227 labeled antibody-chelator conjugate. The trial investigates BAY2315497 alone and in combination with darolutamide, but the specific identity of BAY2315497 as the conjugate is not stated.