Prostate Cancer Clinical Trial
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Summary
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 adult subjects with metastatic castration-resistant prostate cancer (mCRPC).
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 or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies
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
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There are 11 Locations for this study
Los Angeles California, 90095, United States
San Francisco California, 94158, United States More Info
New Haven Connecticut, 06510, United States
Saint Louis Missouri, 63110, United States
New York New York, 10065, United States
Portland Oregon, 97239, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75230, United States
Camperdown New South Wales, 2050, Australia
Bedford Park South Australia, 5042, Australia
Nedlands Western Australia, 6009, Australia
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