Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 225Ac-PSMA-Trillium (BAY3563254)
225Ac-PSMA-Trillium · 1 trial · 2 indications
TEAE: Treatment-emergent adverse event TESAE: Treatment-emergent serious adverse event
DLT: Dose-Limiting Toxicities
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.
PSA50 response is defined as a ≥50% decline in PSA value from baseline (Cycle 1 Day 1).
Best overall PSA response corresponds to the maximum percentage decline or the minimum percentage increase (if no decline) in PSA value from baseline (Cycle 1 Day 1).
| Arm | Type | Description |
|---|---|---|
| Dose escalation of BAY3563254 | EXPERIMENTAL | Participants with advanced mCRPC will receive increased 225Ac-PSMA-Trillium doses in a planned stepwise fashion. |
| Dose expansion group A of BAY3563254 | EXPERIMENTAL | Participants with advanced mCRPC must have received at least 1 but no more than 2 prior taxane-based chemotherapy regimens. No prior treatment with 177Lu-PSMA. |
| Dose expansion group B of BAY3563254 | EXPERIMENTAL | Participants with advanced mCRPC must \*not\* have received taxane-based chemotherapy since becoming castration resistant. No prior treatment with 177Lu-PSMA. |
| Dose expansion group C of BAY3563254 | EXPERIMENTAL | Participants with advanced mCRPC treated with 225Ac-PSMA-Trillium, who have received treatment with an established 177Lu-PSMA therapy and who did not discontinue 177Lu-PSMA treatment due to intolerance. |
| 225Ac-PSMA-Trillium Imaging and Dosimetry | EXPERIMENTAL | The 225Ac-PSMA-Trillium Imaging and Dosimetry Substudy will enroll throughout both dose escalation and dose expansion, starting with the first dose level in dose escalation. The substudy will generally be available at all study sites to participants in the main study. |
| HPGe or NaI Whole Body Radioactivity Measurement of 225Ac-PSMA-Trillium | EXPERIMENTAL | HPGe or NaI measurements of whole-body radioactivity of 225Ac and its daughters as a function of time will be conducted on an optional basis during dose escalation and dose expansion at selected sites to evaluate the clearance of total radioactivity from the body over time. Participants in the 111In-PSMA-Trillium and Tris-POC Imaging Substudy will not be eligible for this HPGe or NaI Whole Body Radioactivity Measurement of 225Ac-PSMA-Trillium Substudy. |
| Name | Type | Description |
|---|---|---|
| 225Ac-PSMA-Trillium (BAY3563254) | DRUG | Intravenous slow injection on Day 1 of a 6 week treatment 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...
225Ac-PSMA-Trillium is an investigational small molecule being developed for the treatment of advanced metastatic castration-resistant prostate cancer (mCRPC). It is designed to target prostate-specific membrane antigen (PSMA), which is expressed in this disease. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
225Ac-PSMA-Trillium targets prostate-specific membrane antigen (PSMA), a protein commonly expressed on prostate cancer cells. By binding to PSMA, the drug aims to deliver a therapeutic effect specifically to cancer cells. This mechanism is being evaluated in patients with advanced metastatic castration-resistant prostate cancer who have PSMA-expressing tumors.
225Ac-PSMA-Trillium is being developed by Bayer AG, a multinational pharmaceutical company. Bayer is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced metastatic castration-resistant prostate cancer. The drug is also known by the code name BAY3563254.
225Ac-PSMA-Trillium is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The ongoing Phase 1 trial is a first-in-human study designed to assess the drug's safety, tolerability, and preliminary activity in patients with advanced metastatic castration-resistant prostate cancer.
225Ac-PSMA-Trillium is being studied in a Phase 1 clinical trial registered as NCT06217822. This first-in-human study is recruiting participants with advanced metastatic castration-resistant prostate cancer and PSMA expression. The trial is enrolling approximately 198 participants across multiple countries, including the United States, Belgium, Canada, Finland, Italy, Japan, Netherlands, Sweden, Switzerland, and the United Kingdom.
Yes, 225Ac-PSMA-Trillium is also known as BAY3563254. Both names refer to the same investigational drug being developed by Bayer AG for advanced metastatic castration-resistant prostate cancer. The drug is a small molecule designed to target PSMA and is currently in Phase 1 clinical trials.