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 therapy being studied in adults with advanced metastatic castration-resistant prostate cancer, or mCRPC. It is also known as BAY3563254. The Phase 1 trial enrolls participants whose tumors express prostate specific membrane antigen (PSMA), a biomarker used to select patients for this treatment.
225Ac-PSMA-Trillium targets prostate specific membrane antigen, or PSMA, a protein expressed on prostate cancer cells. The drug is designed to deliver the alpha-emitting isotope actinium-225 to PSMA-expressing tumor cells. It is being developed for patients with advanced metastatic castration-resistant prostate cancer whose tumors show PSMA expression.
225Ac-PSMA-Trillium is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. The company is running a first-in-human Phase 1 study of the agent in advanced metastatic castration-resistant prostate cancer.
225Ac-PSMA-Trillium is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The ongoing first-in-human study is evaluating the drug in participants with advanced metastatic castration-resistant prostate cancer and PSMA expression.
225Ac-PSMA-Trillium is being studied in the first-in-human trial NCT06217822, titled a study of 225Ac-PSMA-Trillium (BAY 3563254) in participants with advanced metastatic castration-resistant prostate cancer. The trial is currently recruiting, with an estimated enrollment of 198 participants across the United States, Belgium, Canada, Finland, Italy, Japan, the Netherlands, Sweden, Switzerland, and the United Kingdom.
Yes, 225Ac-PSMA-Trillium is also known as BAY3563254. The two names refer to the same investigational compound from Bayer AG. The Phase 1 trial NCT06217822 uses both names in its title to identify the study drug.