Safety, Tolerability and Pharmacokinetics of DCBCI0901 in Patients With Advanced Solid Tumor

Inclusion Criteria:

1. Adult male or female patients, age at consent ≥20 years.
2. Patients with pathologically or cytologically confirmed advanced solid tumor(s), failed to respond to standard therapy.
3. Measurable or non measurable disease on imaging by RECIST v1.1.
4. ECOG PS of 0 and 1.
5. Any acute or chronic clinically significant adverse effects of prior chemotherapy have resolved to ≤Grade 1 as determined by the CTCAE v4.0 criteria.
6. Life expectancy ≥12 weeks.
7. No prior cytotoxic chemotherapy, radiation therapy, or immunosuppressive therapy within 4 weeks of starting study treatment.
8. Have not participated in any other investigational trials within 28 days before commencing the study treatment.
9. Eligible organ function
10. Patients with primary liver cancer or hepatic metastasis are eligible to enroll,
11. No active infections or unstable angina, or myocardial infarction within 6 months or coexisting medical problems of sufficient severity to limit compliance in the study.
12. No known concomitant genetic or acquired immunosuppressive diseases
13. No history of alcoholism, drug addiction or psychotic disorders.
14. Negative urine β human chorionic gonadotropin test in women of childbearing potential at Screening.
15. Patients who agree that they or their partner(s), if WOCBP, will practice contraception during the study period
16. If there is a history of brain metastases or spinal cord compression treated with radiation and/or surgery, the therapy must have occurred at least 3 months prior to enrollment and the metastatic disease must have been stable since completion.
17. Patients who are fully informed about the content of the study by the Investigator using the specified written consent form

Exclusion Criteria:

1. Uncontrolled systemic infection at Screening, including patients who are positive and at risk
2. Severe or poorly controlled systemic illnesses that may affect the conduct or results of the study.
3. Presence of ≥Grade 2 non hematological AEs at Screening for which a causal relationship with prior therapies cannot be ruled out
4. Long QT syndrome,
5. Symptoms of peripheral neuropathy.
6. Concomitant treatment with, or anticipated use of, pharmaceutical, non pharmaceutical agents which are known potent inhibitors for Cytochrome P450
7. Patients on traditional Chinese medicine (TCM) or plan to take TCM.
8. Women who are nursing or pregnant during the study period.
9. Patients who have a history of hypersensitivity to mTOR inhibitors or any of the ingredients.
10. Patients who cannot communicate reliably with the Investigator.
11. Patients who are unlikely to cooperate with the requirements of the study.
12. Other cases judged by the Investigator to be ineligible for participation in the study.