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A PHASE 1, OPEN-LABEL, MULTICENTER STUDY OF JANX007 IN SUBJECTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Status: Recruiting
This study tests whether the study drug, a T-cell engager therapy engineered to have fewer off-target effects by increasing its specificity to tumor cells, is safe and tolerable in subjects with metastatic castration-resistant prostate cancer (mCRPC) The study will also assess the potential Phase 2 dose regimens and determine a recommended Phase 2 dose.
Sex: Male
Age Group: 18 years and over
Inclusion Criteria:
• 18 years to 100 years old
• confirmed adenocarcinoma of the prostate
• Metastatic Castration-resistant Prostate Cancer (mCRPC) that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:
• prior solid organ transplant
• treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
• significant cardiovascular disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), Castration Resistant Prostatic Cancer, mCRPC, Metastatic Castration-resistant Prostate Cancer
Study Contact: Skylar Mast - smast@umn.edu
Principal Investigator: Nicholas Zorko
Phase: PHASE1
IRB Number: STUDY00024313
See this study on ClinicalTrials.gov