Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY3546828 · 1 trial · 1 indication
DLTs will be summarized by MedDRA system organ class, preferred term and worst CTCAE grade.
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per PCWG3 guidelines, as assessed by the Investigator.
PSA partial response is defined as a ≥50% decline in PSA value from Cycle 1 Day 1 (baseline). This PSA decline must be confirmed to be sustained by a second PSA value obtained 3 to 4 or more weeks later.
| Arm | Type | Description |
|---|---|---|
| Dose escalation of BAY3546828 | EXPERIMENTAL | Participants with advanced metastatic castration-resistant prostate cancer (mCRPC) will receive 225Ac-pelgi dose in a stepwise fashion, according to a predefined dose escalation scheme |
| Dose expansion group A of BAY3546828 | EXPERIMENTAL | Participants with advanced mCRPC with at least 1 but no more than 2 prior taxane regimens. No prior radionuclide therapy |
| Dose expansion group B of BAY3546828 | EXPERIMENTAL | Participants with advanced mCRPC who have not received taxane chemotherapy since becoming castration-resistant. No prior radionuclide therapy. |
| Dose expansion group C of BAY3546828 | EXPERIMENTAL | Participants with advanced mCRPC after prior Lutetium-177 labeled PSMA ligand (177Lu-PSMA) treatment. |
| Name | Type | Description |
|---|---|---|
| BAY3546828 | DRUG | Intravenous (IV) infusion on Day 1 of each cycle. |
Inclusion Criteria: * mCRPC with pathological confirmation of adenocarcinoma without small-cell or neuroendocrine features. * Previous treatment with at least 1 Novel androgen axis drug (NAAD) (e.g., enzalutamide, apalutamide, darolutamide and/or abiraterone). * Prior orchiectomy and/or ongoing and...
BAY3546828 is an investigational small molecule developed by Bayer AG for advanced metastatic castration-resistant prostate cancer (mCRPC). It is being studied in a Phase 1 clinical trial to assess its safety, how it affects the body, how it moves through the body, and its anticancer activity in participants with this disease.
BAY3546828 is being evaluated for the treatment of advanced metastatic castration-resistant prostate cancer (mCRPC) in adult men. The Phase 1 study enrolls participants with advanced mCRPC and examines the study treatment's safety, tolerability, pharmacokinetics, and anticancer activity. It is investigational and has not been established as a treatment outside clinical research.
BAY3546828 is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is sponsoring the Phase 1 clinical program evaluating the compound in advanced metastatic castration-resistant prostate cancer.
BAY3546828 is in Phase 1 clinical development. It is investigational and is being studied in a single active Phase 1 trial in advanced metastatic castration-resistant prostate cancer; it is not an approved therapy.
BAY3546828 is being studied in trial NCT06052306, a Phase 1 study in advanced metastatic castration-resistant prostate cancer. The trial is active but not recruiting, is controlled, enrolls approximately 85 male participants aged 18 years and older, and is conducted in Canada, Finland, the Netherlands, and the United Kingdom.
Yes. The Phase 1 trial of BAY3546828 in advanced metastatic castration-resistant prostate cancer is biomarker selected, meaning enrollment is guided by a biomarker-defined patient population rather than an unselected group.