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A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

A Phase 2, Randomized, Open-Label, Study of Lorigerlimab with Docetaxel or Docetaxel Alone in Participants with Metastatic Castration-Resistant Prostate Cancer

  • Clinical Trial Information

    Trial Contact: Djuro, Victor

    Trial Phone: 321.841.7477

  • IRB No: Pro00071445

    Protocol Abbrev: CP-MGD019-02

    Principal Investigator: Hatem Hassanein, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: CP-MGD019-02

    ClinicalTrials.gov ID: NCT05848011

  • Objective

    The purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (MCRPC) who receive lorigerlimab in addition to the standard of care (SOC) of docetaxel and prednisone. About 150 participants with mCRPC will be enrolled. Participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm).

  • Key Eligibility

    Inclusion Criteria:
    •   Metastatic castration-resistant adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
    •   Participants must have ≥ 1 metastatic (measurable or non-measurable per PCWG3) lesion.
    •   Participant has prostate cancer progression at study entry based on PCWG3 criteria.
    •   Participant has received at least 1 and no more than 2 prior androgen receptor axis-targeted therapy (ARAT) regimens (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide) for mCRPC.
    •   Patients with known history of documented breast cancer gene (BRCA) mutation (germline or somatic) must have received an approved poly ADP ribose polymerase (PARP) inhibitor regimen.
    •   Participants must have adequate performance status, life expectancy and laboratory values.