SyB C-0501(Oral Bendamustine) in Patients With Advanced Solid Tumors

Inclusion criteria

• 20 years of age or greater at the time of informed consent
• Part 1: Patients with histologically or cytologically confirmed advanced solid tumors refractory to standard therapies or without standard therapies.
• Part 2: patients with advanced solid tumors* refractory to standard therapies or without standard therapies.

• *metastatic breast cancer, small cell lung cancer and other tumors decided based on the Part 1 results
• ECOG performance status 0-1
• Patients with adequate bone marrow, liver, renal, cardiac and pulmonary function as assessed by the following:

• Absolute neutrophil count (ANC) ≥ 1500/μL, who has not received supportive care of treatment with GCS within 2 weeks before the entry
• Platelet count ≥ 100,000/μL and Hemoglobin ≥ 9g/dL in patients received no blood transfusions within 2 weeks before the study entry
• Serum creatinine ≤ 1.5 x upper limit normal (ULN) or estimated creatinine clearance ≥ 50 mL/min using Cockcroft-Gault equation
• Serum total bilirubin ≤ 1.5 x ULN in patients not suffering from Gilbert's syndrome
• ALT and AST ≤ 3.0 x ULN (≤ 5.0 x ULN if liver lesions)
• 12-lead ECG normal
• LVEF ≥ 55% by echocardiography
• SpO2 ≥ 95% or PaO2 ≥ 65mmHg
• Acute toxicity in prior treatment has recovered to baseline or CTCAE Grade 0-1 except the adverse events that, in the judgment of the investigator or sub-investigator, would not provide safety risks in the study.
• Serum/urine pregnancy tests performed before the study entry are negative.
• Male and female patients of childbearing potential should give their consent to use adequate contraceptive measures during the study and 180 days after completing study treatment.
• Provision of written, signed and dated informed consent by the patient or legally acceptable representative after the receipt of adequate information regarding the study
• Ability to understand participation in the study, visiting/treatment plan, sampling/analyses and other study procedures; and willingness to follow them

Exclusion criteria

• Active, uncontrollable or symptomatic metastatic tumors in CNS
• Complications of interstitial lung disease, pulmonary fibrosis and emphysema diagnosed by chest-X ray or CT scan
• Medical history of radiation, idiopathic or drug-induced pneumonitis
• Major surgery within 4 weeks before study entry or planning it within 4 weeks
• Treatment with immunotherapy, therapeutic antibody or biologics within 4 weeks or their 5 half-lives before study entry, whichever is longer
• Treatment with cytocidal chemotherapy or hormonal therapy within 14 days
• Radiotherapy within 4 weeks before study entry
• Palliative radiotherapy to control metastatic bone pain within 7 days before study entry
• Malabsorption syndrome or full/partial gastric resection
• Patients intolerable to oral administration in the judgment of the investigator or sub-investigator
• Patients under following medical treatment

• Anticancer therapy approved for advanced cancers
• Study treatment in other clinical trials
• Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) detected in blood test
• Lactating women
• Medical history of allergy to the agents similar to the investigational drug such as alkylating agents or purine nucleoside derivatives
• Medical history of allergy to Polyoxyl 40 hydrogenated castor oil or gelatin capsule
• Severe acute or chronic physical/mental condition or laboratory abnormalities which could interfere with evaluation of study treatment or results, or which is likely to progress/worsen due to the participation in the study or administration of SyB C-0501
• Any condition that, in the opinion of the investigator or sub-investigator, makes the patient inappropriate for the study participation.