drugset / Trial / NCT02502994

Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC

NCT02502994 ↗

Phase 1 Unknown 12 enrolled Norio Nonomura
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2015-05
Primary completion
2016-12
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject GEN0101 Unknown 30000 unknown Intrathecal
Subject GEN0101 Unknown 60000 unknown Intrathecal