Solid Tumors
Conditions
Interventions
OTS11101 1.0mg/ml will be administered by subjection Once a week at 4 times.Transition to the next cohort will be decided following evaluation of the development of DLT.
OTS11101 2.0mg/ml will be a
Sponsors
Oncotherapy science,Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with histologically or cytologically documented advanced solid tumors. (2) Patients who are refractory to standard therapy or for which no standard therapy is available. (3) Patients must be >=20 years old at the time of obtaining informed consent. (4) ECOG Performance Status must be 0 or 1. (5) Patients must have HLA-A*2402. (6) Life expectancy must be >=3 months. (7) Patients who are free of marked failure of major organ function, more over the following criteria must be satisfied in laboratory tests. 1. Hematopoietic function White blood cell count: >=3000/mm3, <=12000/mm3 Hemoglobin: >=9g/dl Platelet count: >=100000/mm3 (G-CSF, Erythropoetin, Blood products and transfusion must be untried within 2 weeks days before registration.) 2. Hepatic function AST and ALT: <=2.5*Upper Limit of Normal(ULN),<=5.0*ULN in case of patients have metastasis in the liver. Total bilirubin:<=1.5*ULN 3. Renal function Cre: <=1.5*ULN (8) Patients meeting the criteria of washing out period from the completion of the previous cancer treatment to the start date of OTS11101 administration. 1. Chemotherapy, Surgical remedy, Investigational products: >=4 weeks Bisphosphonate: >=2 weeks 2. Radiotherapy: >=2 weeks Exclude the patient who has been irradiated at all sites of administration in this study where the injection is administrated in this study. 3. Systemic corticosteroid administration: >=2 weeks (9) Patients who can be hospitalized for the period provided for protocol. (10) Informed consent must be obtained.
Exclusion criteria
Exclusion criteria: (1) Symptomatic brain metastasis. (2) Pleural effusion, ascites fluid, pericardial fluid requiring drainage. (3) Unhealed traumatic lesion, including traumatic fracture. (4) History of clinically important bleeding. (5) History of myocardial infarction, severe unstable angine pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OTS11101. (6) Uncontrolled hypertension (Systolic pressure>=140mmHg, Diastolic pressure>=90mmHg), serious arrhythmia or cardiac failure. (7) Other serious complication. (8) Patients who require systemic administration of the following agents during the study treatment period. 1. Corticosteroid 2. Anticoagulant 3. Immunosuppresant, Immunostimulant 4. G-CSF 5. Erythropoietin (9) Current participation in other drug clinical trials. (10) Woman who is pregnant, breast feeding and child-bearing potential. (11) Patient or patients partner unwilling to use adequate contraception during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female. (12) As determined by the principal investigator or the sub-investigator the subject are not adequate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse event and Dose-Limiting Toxicity(DLT). | — |
Countries
Japan
Outcome results
None listed