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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:07/27/2023

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

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