Phase Ia/Ib multicenter investigator initiated trial of Mogamulizumab for advanced or recurrent cancer.
- Conditions
- Advanced or recurrent cancer
- Registration Number
- JPRN-UMIN000010050
- Lead Sponsor
- Aichi Medical University School of Medicine, Department of Tumor Immunology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 58
Not provided
(1) Patients with HIV antibody positive. (2) Patients with HCV antibody positive. (3) Patients with autoimmune disease. (4) Patients with HBs antigen or HBV-DNA positive. (5) History of serious anaphylaxis induced by antibody preparation. (6) Patients with double cancer. (7) Within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease. (8) Pregnant or breast-feeding females and females who have a possibility of pregnancy. (9) Patients with active infection. (10) Patients with psychosis or dementia. (11) Patients who need continuous systemic administration of adrenocorticosteroid. (12) Patients who have received hematopoietic stem cell transplantation. (13) Patients who have presence or suspicion of CNS involvement. (14) Patients who are administered the other investigational product within 4 weeks of the entry. (15) Patients treated with immunotherapy for cancer (e.g. cancer vaccine therapy) within 12 weeks of the entry. (16) Any other inadequacy for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <Phase Ia> Maximum tolerated dose(MTD) Dose limiting toxicity(DLT) Adverse events Pharmacokinetics <Phase Ib> Adverse events Effect of Treg depletion
- Secondary Outcome Measures
Name Time Method <Phase Ia> Effect of Treg depletion Response rate Progression-free survival(PFS) Overall survival(OS) <Phase Ib> Response rate Progression-free survival(PFS) Overall survival(OS) To determine recommended dose of Mogamulizumab