MC# 22-27 - A Phase I, Open-label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer
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Agent(s): JANX007
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Disease Type(s): Prostate
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Phase(s): I
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Drug Classification(s): Immunotherapy, Targeted Therapy
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Molecular Target(s): PSMA
Mechanism of Action
JANX007 is a Tumor Activated T Cell Engager therapeutic targeting prostate-specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer.
Purpose
In this study, the sponsor and investigators want to learn:
- How much of JANX007 can be given with an acceptable level of side effects
- The effects of JANX007 (good and bad)
- How much of JANX007 is absorbed into the blood and how fast it is removed
- If the body’s immune system has a response to JANX007
Inclusion Criteria
- Male subjects ≥18 years of age at the time of signing informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Progressive mCRPC or intolerance to the most recent therapy
- PSMA expressing tumor
- Adequate organ function
Exclusion Criteria
- Prior solid organ transplant
- Prior treatment with PSMA-targeted CAR-T cell therapy
- Clinically significant cardiovascular disease
- HIV or acute/chronic hepatitis C infection
- Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
