Phase I Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral Administration of GEN0101 in Patients with Advanced Melanoma.
- Conditions
- Advanced Melanoma
- Registration Number
- JPRN-UMIN000012943
- Lead Sponsor
- Department of Dermatology Course of Integrated Medicine Graduate School of Medicine, Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
1) The patient has multiple brain metastases. 2) The patient shows positive immune response by GEN0101 prick test at screening. 3) The patient has a uncontrolled serious complication such as active infection. 4) Chemotherapy, radiotherapy, local IFN-b therapy, and/or any other therapy with established or suggested anti-cancer effects within 4 weeks (in case of Nitrosoureas or Mitomycin C: within 6 not 4 weeks). 5) Participation in another clinical trial of another investigational medical product within 4 weeks. 6) History of a second independent malignancy within 5 years. 7) History of active autoimmune disease 8) The patient is undergoing on systemic corticosteroids or immunosuppressive agents except for the use of maximum 10 mg/day oral prednisolone over 6 months. 9) The patient is a pregnant or lactating female. 10) The patient has any serious psychiatric disorders that may be unwilling or unable to comply with protocol requirements and scheduled visits. 11) The patient has a history of a transplantation of the allogeneic ogan, the autologous ogan or tissue. 12) The patient shows adequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range. 13) The patient has hepatitis Be antigen, hepatitis C antibody or human immunodeficiency virus (HIV1,2) antibody positive status. 14) The Patient is inappropriate to be enrolled in this study judged by the doctors in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessing the Safety and Tolerability of GEN0101
- Secondary Outcome Measures
Name Time Method Assessing the antitumor immunity and validity of GEN0101