Castration Resistant Prostate Cancer Clinical Trial
Official title:
Phase 1 Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral and Subcutaneous Administration of GEN0101 in Patients With Recurrence of Castration Resistant Prostate Cancer
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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