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A Phase 1 Open-label, First-in-human, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Actinium-225-macropa-pelgifatamab (BAY 3546828) in Participants With Advanced Metastatic Castration Resistant Prostate Cancer (mCRPC)

Trial Profile

A Phase 1 Open-label, First-in-human, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Actinium-225-macropa-pelgifatamab (BAY 3546828) in Participants With Advanced Metastatic Castration Resistant Prostate Cancer (mCRPC)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Mar 2025

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At a glance

  • Drugs BAY-3546828 (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Bayer
  • Most Recent Events

    • 12 Dec 2024 Planned number of patients changed from 140 to 232.
    • 16 Sep 2024 Planned End Date changed from 16 Jun 2031 to 10 Aug 2031.
    • 07 Oct 2023 Status changed from not yet recruiting to recruiting.

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