Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Male ≥18 years of age at the time of signing informed consent
  2. Histologically or cytologically confirmed adenocarcinoma of the prostate
  3. 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
  4. Adequate organ function

EXCLUSION CRITERIA

Exclusion Criteria:

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

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition
Prostate Cancer,Metastatic Castration-resistant Prostate Cancer,Castration Resistant Prostatic Cancer
Age (in years)
18 - 100
Phase
Phase 1
Participants needed
105
Est. Completion Date
Mar 31, 2025
Treatment type
Interventional

Sponsor
Janux Therapeutics
ClinicalTrials.gov identifier
NCT05519449
Study number
PSMA-007-001

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