NCT02502994

Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Norio Nonomura · Academic / Other
• Sex: Male
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Castration Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	GEN0101

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-12-01
• First posted: 2015-07-20
• Last updated: 2015-07-20

Locations

1 site across 1 country: Japan