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New treatment option for Advanced Metastatic Castration-resistant Prostate Cancer
Official title First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)
ClinicalTrials.gov ID: NCT06217822
What this study is testing
What is 225Ac-PSMA-Trillium (BAY3563254)?
225Ac-PSMA-Trillium (BAY3563254) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced metastatic castration-resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers are looking for a better way to treat participants who have metastatic castration-resistant prostate cancer (mCRPC). mCRPC is a cancer of the prostate (male reproductive gland found below the bladder) that has spread to other parts of the body.
- Phase 1: an early, usually small safety study
- Time commitment: about 6 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 androgen deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL or \<1.7 nmol/L).
- Prior taxane treatment:
- Dose Escalation: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for...
You likely can't join if
- Participants who have any of the following tumor lesions which are PSMA negative AND meet the size criteria below are excluded as determined by the...
- a. Any single or multiple lymph node(s) ≥2.5 cm in the short axis.
- b. Any solid organ metastasis (e.g., lung, liver, adrenal glands, etc.) that is ≥1 cm in the short axis.
- c. Any bone metastasis with a soft tissue component ≥ 1 cm in short axis with the soft tissue component being PSMA-negative. PSMA-negative osseous...
- d. Predominantly necrotic lesions with greater than 1 cm of enhancing tissue on contrast-enhanced computed tomography / magnetic resonance imaging...
- Prior systemic anticancer therapy including chemotherapy, NAAD, biologic therapy, immunotherapy, or investigational therapies within 4 weeks of the...
See the full eligibility criteria
Who can join
- 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 androgen deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL or \<1.7 nmol/L).
- Prior taxane treatment:
- Dose Escalation: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician
- Dose Expansion Group A: Participants must have had prior treatment with at least 1 but no more than 2 taxane regimens, in the castration-resistant setting
- Dose Expansion Group B: Participants must not have received any taxane regimens since becoming castration-resistant
- Dose Expansion Group C: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician
- Prior treatment with an established Lu-PSMA therapy (i.e., dose activity and cycles comparable to approved treatments) is required for participants in Dose Expansion Group C only. More specifically, to qualify for this...
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements within 30 days before start of study intervention, as indicated below. Note that blood transfusions (red blood...
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1500/mm\^3
- Platelet count ≥100,000/mm\^3
- Total bilirubin ≤1.5 x the Upper limit of normal (ULN), or ≤3×ULN if the participant has a confirmed history of Gilbert's syndrome (note that participants with Gilbert's syndrome should be carefully evaluated for other...
- Alanine transaminase (ALT) and Aspartate transaminase (AST) ˂2.5 x ULN (≤5 x ULN for participants with liver involvement)
- Participants on a stable dose of anticoagulation therapy are allowed to participate if they have no sign of bleeding or clotting, and prothrombin time international normalized ratio (PT/INR) and activated partial...
- Estimated glomerular filtration rate (eGFR) \>60 mL/min/1.73 m\^2, according to the Modified Diet in Renal Disease (MDRD) abbreviated formula and serum creatinine ≤1.5 x ULN
- Participants must have at least one PSMA-positive (prostate-specific membrane antigen) distant metastatic lesion on the screening PSMA PET/CT scan using the study-designated PSMA PET tracers, as determined by the site...
- Documented progressive mCRPC per PCWG3, and a minimum starting PSA value of 2.0 ng/mL is mandatory. Progressive mCRPC is defined as meeting at least one of the following criteria:
- PSA progression (defined as 2 consecutive increases over a previous reference value obtained at a minimum of 1-week
- Radiological progression in soft-tissue lesions according to PCWG3 modification of RECIST v1.1 criteria
- Progression of bone disease (defined as ≥ 2 new bone lesions according to PCWG3 bone scan criteria)
What rules you out
- Participants who have any of the following tumor lesions which are PSMA negative AND meet the size criteria below are excluded as determined by the site Investigator. A PSMA-negative lesion for eligibility purposes must...
- a. Any single or multiple lymph node(s) ≥2.5 cm in the short axis.
- b. Any solid organ metastasis (e.g., lung, liver, adrenal glands, etc.) that is ≥1 cm in the short axis.
- c. Any bone metastasis with a soft tissue component ≥ 1 cm in short axis with the soft tissue component being PSMA-negative. PSMA-negative osseous metastases without a soft tissue component do not exclude a participant.
- d. Predominantly necrotic lesions with greater than 1 cm of enhancing tissue on contrast-enhanced computed tomography / magnetic resonance imaging (CT/MRI).
- Prior systemic anticancer therapy including chemotherapy, NAAD, biologic therapy, immunotherapy, or investigational therapies within 4 weeks of the start of study treatment, except luteinizing hormone-releasing hormone...
- Prior radiopharmaceutical treatment using actinium-225. Other prior radiopharmaceutical treatments:
- Dose escalation and Dose expansion Groups A and B: Prior treatment with a radiopharmaceutical is prohibited, with the exception of prior treatment with radium-223 dichloride more than 3 months before the start of study...
- Dose expansion Group C: Prior treatment with a radiopharmaceutical is prohibited with the following exceptions: Prior treatment with radium-223 dichloride more than 3 months before the start of study intervention is...
- Prior definitive therapy (radiotherapy or surgery) completed less than 6 weeks before the start of study intervention. Note that palliative radiotherapy completed less than 6 weeks before the start of study intervention...
- Toxic effects of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥2 from prior anticancer therapy not yet stabilized or where significant post-treatment toxicities have been observed. Chronic toxic...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Minneapolis, Minnesota, United States
- Omaha, Nebraska, United States
- Houston, Texas, United States
- Anderlecht, Brussels Capital, Belgium
- Leuven, Flemish Brabant, Belgium
- Kortrijk, West Flanders, Belgium
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Kuopio, Northern Savonia, Finland
- Tampere, Pirkanmaa, Finland
- Turku, Southwest Finland, Finland
- Helsinki, Uusimaa, Finland
- Milan, Italy
- Naples, Italy
- Yokohama, Kanagawa, Japan
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Minneapolis, Minnesota, United States; Omaha, Nebraska, United States; Houston, Texas, United States; Anderlecht, Brussels Capital, Belgium; Leuven, Flemish Brabant, Belgium and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.