Solid tumor
Conditions
Interventions
OTS102 0.5mg/mL will be administrated by sunjection Once a week at 4 times. Transition to the next cohort will be decided following evaluation of the development of DLT.
OTS102 1.0mg/mL will be admin
Sponsors
OncoTherapy Science, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with histologically or cytologically documented advanced solid tumors. Only for liver, biliary, or pancreas cancers, accept the diagnostic imaging technique. 2)Patients who are refractory to standard therapy or for which no standard therapy is available. 3)Age 20 years and older at the time of obtaining informed consent. 4)Eastern Cooperative Oncology Group (ECOG) Performance States (PS) of 0 to 1 5)Histocompatibility Locus Antigen (HLA)-A*2402 6)Life expectancy is 3 months or longer 7)Patients who are free of marked failure of major organ function. 8)Patients meeting the criteria of washing out period from the completion of the previous cancer treatment to the start date of OTS102. 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 drenege 3)Unhealed traumatic lesion 4)Hemorrhagic diathesis or severe coagulopthy, and patients with those histories 5)hemoptysis or lung hemorrhage or gastrointestinal bleeding, and patients with those histories 6)uncontrolled hypertension (systolic:140 mmHg and over, diastolic: 90 mmHg and over), or serious arrhythmia or heart failure 7)serious complication, equivalent to CTCAE grade 3 or greater 8)Patients who require systemic administration of the following agents during OTS102 study medication period. -Corticosteroid, Anticoagulant drug, Immunosuppresant, Immunostimulant -Granulocyte Colony Stimulating Factor (G-CSF), Granulocyte, Macrophage Colony Stimulating Factor (GM-CSF), Erythropoietin (EPO) 9)Participating in drug clinical trials 10)Woman who is pregnant, breast feeding and child-bearing potential. 11)Patient or patient's partner unwilling to use adequate contraception. 12)As determined by the principal investigator or the sub-investigator the subject has difficulties that would prevent the subject's ability to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse event and Dose-Limiting Toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (Tumor resuponse assessment based on the Response Evaluation Criteria in Solid Tumor [RECIST] guidelines) | — |
Countries
Japan
Outcome results
None listed