Phase 1 Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral and Subcutaneous Administration of GEN0101 in Patients with Chemotheapy-resistant Malignant Pleural Mesothelioma (Phase I).
- Conditions
- Chemotheapy-resistant Malignant Pleural Mesothelioma
- Registration Number
- JPRN-UMIN000019345
- Lead Sponsor
- Osaka University Hospital, Center for respiratory
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
Not provided
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, radiotherapy or immunotherapy within 6 weeks before planned registration date 5) Received another investigational product within 4 weeks before the informed concent 6) Had a history of othr malignancy, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration 7) Have a interstitial pneumonia or fibrosing disease of the lung that need treatment 8) Have an active autoimmune disease 9)Receiving systemic administration of glucocorticosteroid which restrains immunity response. 10) Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication) 11) 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 12) Pregnant or lactating women, except for the woman who discontinue to lactate (from the day of a written informed consent to the day after 30days of discontinue the administration) In the case of womane, to conduct beta-HCG tests to confirm the presenceor absence of pregnancy 13) Positive result of the hepatitis B surface antigen, HCV antibody or HIV test at the screening visit 14) Inappropriate to be enrolled in this study judged by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of DLT
- Secondary Outcome Measures
Name Time Method 1)Effect of tumor shirinkage - RECIST - Tumor marker (SMRP, CYFRA) 2)Induction of antitumor immunity - NK cell - IL-6 - IFN-gammma 3)Blood concentration of GEN0101/HVJ-E