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 - Phase 1 study of GEN0101 in patients with recurrence of CRPC

Osaka University0 个研究点目标入组 12 人开始时间: 2015年4月15日最近更新: 2023年10月17日

适应症

试验速览

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•1) Have multiple brain metastases 2) Positive result of the prick test of GEN0101 3) Have serious complications such as uncontrolled active infection 4) Received systemic chemotherapy within 3 weeks before planned registration date or received radiotherapy or immunotherapy within 6 weeks before planned registration date /However the hormone therapy except for the estramustine, enzalutamide and abiraterone, bisphosphonate and anti-RANKL antigen antibody are not included in the systemic chemotherapy. 5) Received another investigational product within 4 weeks before the informed concent 6) Had a history of malignancy other than prostate cancer, except for the relapse-free and metastatis-free for more than 5 years after the last treatment at the registration 7) Have an active autoimmune disease 8)Receiving systemic administration of glucocorticosteroid which restrains immunity response, except for the administration for a long period (over 6 months) of the low dose (equivalent to under 10 mg/day oral prednisolone). 9) Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication) 10) PT(%) less than 10% of the lower limit of normal or APTT more than 1.5 times of the upper limit of normal of local reference range at the screening visit 11) Positive result of the hepatitis B surface antigen, HCV antibody or HIV test at the screening visit 12) Inappropriate to be enrolled in this study judged by the investigators

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