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 being studied for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.
BAY3546828 is a small molecule that is being studied for its anticancer activity. The specific molecular target of BAY3546828 has not been disclosed in the available information, so its precise mechanism of action is not publicly detailed.
BAY3546828 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the over-the-counter market. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
BAY3546828 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is designed to assess the drug's safety, how it affects the body, and its anticancer activity in patients with advanced metastatic castration-resistant prostate cancer.
BAY3546828 is being studied in a Phase 1 clinical trial registered as NCT06052306. This trial is active but not recruiting participants, with a planned enrollment of 232 patients. The study is evaluating the safety, pharmacokinetics, and anticancer activity of BAY3546828 in patients with advanced metastatic castration-resistant prostate cancer.
Yes, BAY3546828 is also known as Actinium-225-macropa-pelgifatamab. The clinical trial NCT06052306 refers to the study treatment as Actinium-225-macropa-pelgifatamab (BAY3546828), indicating that these names refer to the same investigational drug.