This study is designed to evaluate the safety and efficacy of a single injection of GEN0101 in patients with recurrence of castration resistant prostate cancer. The subjects receive GEN0101 injection 4 times per two weeks (1st intratumoral injection and followed subcutaneous injection) and two weeks of observation as one cycle treatment period. Each subject receive two cycle treatment period. Low dose group: 30,000m NAU per injection of GEN0101 High dose group: 60,000m NAU per injection of GEN0101 Each group included minimal 3 subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Urology, Osaka University Hospital
Suita, Osaka, Japan
RECRUITINGDLT (Dose Limiting Toxicity)
To determine the appropriate dosing strategy for GEN0101 for castration resistant prostate cancer
Time frame: 8 weeks
Number of participants with tumor shrinkage according to the RECIST.
Time frame: 8 weeks
Change from baseline in tumor marker (PSA: Prostate Specific Antigen, NSE: Neuron-specific enolase, CEA: Carcinoembryonic Antigen, and CA19-9: Carbohydrate Antigen19-9) at Cycle 1, Week 4 and at Cycle 2, Week 4.
Time frame: 8 weeks
Change from baseline in prostate histological evaluation at Cycle2, Week2.
Time frame: 8 weeks
Change from baseline in induction of antitumor immunity (NK cell activity, IL-6 and IFN-gamma) at Cycle1, Week 2 and Week 4 and at Cycle2, Week 2 and Week 4.
Time frame: 8 weeks
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