Advanced or recurrent cancer
Conditions
Interventions
<
Phase Ia>
Mogamulizumab 0.1mg/kg will be administered 8 times every week.
<
Mogamulizumab 0.5mg/kg will be administered 8 times every week.
<
Mogamulizumab 1.0mg/kg will be administered 8 times every week.
<
Phase Ib>
Mogamulizumab of the tolerated dose in Phase Ia will be administered 8 times every week.
<
Mogamulizumab 0.1mg/kg will be administered 8 times every week.
Sponsors
Aichi Medical University School of Medicine, Department of Tumor Immunology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Tumor cells are judged CCR4 negative, and patients with lung cancer, stomach cancer, esophageal cancer, malignant melanoma or ovarian cancer, which is histologically confirmed. (2) Patients with refractory or intolerable to standard therapy, patients who have no standard therapy or refuse standard therapy. (3) Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2. (4) Patients should be 20 years or older at informed consent. (5) No serious disorder of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ; 1) WBC count : >=1,500/mm3 2) Hemoglobin : >=8.0g/dL 3) Platelet count : >=75,000/mm3 4) Serum total bilirubin : <=2.0 x ULN 5) AST and ALT : <=2.5 x ULN (Patients with hepatic infiltration which is attributed to primary disease<=5.0 x ULN) 6) Serum creatinine : <=1.5 mg/dL 7) SpO2 : >=93 % 8) ECG : No abnormal findings. 9) EF : >=50 % (6) Agree to use birth control including condom etc. from the time of obtaining the first consent to 24 weeks after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization). (7) Given written informed consent. (8) Patients who can be hospitalized from the day of first administration to the next day. (9) Patients who have target lescion(s) measurable by RECIST ver.1.1. (10) Life expectancy >= 3 months.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Phase Ia> Maximum tolerated dose(MTD) Dose limiting toxicity(DLT) Adverse events Pharmacokinetics <Phase Ib> Adverse events Effect of Treg depletion | — |
Secondary
| Measure | Time frame |
|---|---|
| <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 | — |
Countries
Japan
Contacts
Public ContactHiroshi Miyamoto
Secretariat of clinical trial coordinating committee (none)
Outcome results
None listed