First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)

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. This type of prostate cancer does not respond to hormone treatment used to lower the level of testosterone, a male sex hormone, to prevent cancer from growing. The study treatment 225Ac-PSMA-Trillium, also called BAY3563254, is under development to treat advanced metastatic castration-resistant prostate cancer. It works by binding to PSMA

Trial Details

NCT ID

NCT06217822

Phase

PHASE1

Sponsor

Bayer

Status

RECRUITING

Cancer Type

Prostate Cancer

Interventions

225Ac-PSMA-Trillium (BAY3563254)

Locations (sample)

Duarte, California, United States|34.13945,-117.97729
Minneapolis, Minnesota, United States|44.97997,-93.26384
Omaha, Nebraska, United States|41.25626,-95.94043
Houston, Texas, United States|29.76328,-95.36327
Anderlecht, Brussels Capital, Belgium|50.83619,4.31454

Key Eligibility 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 androgen deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL or \<1.7 nmol/L).
Prior taxane treatment:

For full eligibility, visit ClinicalTrials.gov.

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