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Phase I

A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

  • Study HIC#:2000034572
  • Last Updated:03/17/2024

This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 administered as a single agent in adults with metastatic castration-resistant prostate cancer (mCRPC).

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    Eligibility Criteria

    Inclusion Criteria:

    • Male ≥18 years of age at the time of signing informed consent
    • Histologically or cytologically confirmed adenocarcinoma of the prostate
    • Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible
    • Adequate organ function

    Exclusion Criteria:

    • Prior solid organ transplant
    • Prior treatment with PSMA-targeted CAR-T cell therapy
    • Clinically significant cardiovascular disease
    • Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
    • Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment

    Principal Investigator


    For more information about this study, including how to volunteer, contact: