Trial intelligence / Profile preview

First-in-human Phase 1 study of 225Ac-PSMA-Trillium in metastatic castration-resistant prostate cancer

jRCT2031260269Phase 1Recruiting

Sponsor
Bayer
Start
Aug 2026
Modality
Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Small Molecules
01

Overview

Phase 1, open-label trial of BAY 3563254 in metastatic castration-resistant prostate cancer (mCRPC) (4 arms), sponsored by Bayer. Primary endpoints: Incidence and severity of treatment-emergent adverse events (TEAEs) including treatment-emergent serious adverse events (TESAEs) in dose escalation, Recommended safe and active dose (RSAD) based on incidence of dose-limiting toxicities (DLTs) and preliminary activity (ORR, PSA50) and 4 more. Started Aug 2026; status: recruiting.

02

Drugs

BAY 3563254
03

Conditions

metastatic castration-resistant prostate cancer (mCRPC)

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