A Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy

This is an open-label, single-arm, dose-escalation, safety and tolerability study. Eligible subjects will be assigned to a SCB01A dose level at the time of study entry and scheduled to receive two treatment cycles with SCB01A for the observation of DLT. A treatment cycle is defined as a three-hour infusion of SCB01A given every 21 days. Unless any off-study criteria are met, the study period of each subject can be up to two cycles.

Inclusion criteria

• Subjects who are at least 18 years of age.
• Have provided written informed consent prior to the initiation of study procedures.
• Have histologically or cytologically confirmed diagnosis of an advanced solid tumor that has failed to respond to all available standard treatments.
• Have ECOG PS scale of 0-1 at the time of enrollment.
• Have adequate organ function:

• Bone marrow function:

• White blood cell count (WBC) ≥ 4000/μL
• Absolute neutrophil count (ANC) ≥ 1500/μL
• Hemoglobin ≥ 10.0 g/dL
• Platelet count ≥ 100,000/μL
• Hepatic Function:

• Serum total bilirubin level ≤ 1.0 x upper normal limit
• Serum alanine aminotransferase (ALT) level ≤ 2.5 x upper normal limit
• Renal Function:

• Serum creatinine ≤ 1.0 x upper normal limit and creatinine clearance (estimated by Cockcroft-Gault formula) > 60 mL/min
• Heart Function:

• Ejection fraction ≥ 55%
• QTC < 450 msec
• Have a life expectancy of at least 3 months
• Have negative serum pregnancy test within 1 week before study drug administration (for women of childbearing potential and not diagnosed as germ cell tumor with beta-HCG only).
• Are willing to practice medically accepted contraception (if the risk of contraception exists) throughout the study period (from screening until Final Visit).

Exclusion criteria

• Subjects who have failed to recover from prior anti-cancer treatment-related toxicities, e.g. surgery, chemotherapy, radiotherapy, target therapy, biologic therapy, immunotherapy, alternative medicine, hormonal therapy, or investigational agent(s).
• Treatment with an investigational drug, chemotherapy, targeting agent(s), biologic therapy (e.g., IL-2, Interferon, etc.), immunotherapy (e.g. tumor vaccine, etc.), alternative medicine or hormonal therapy (e.g. anti-estrogens, anti-androgens, etc.), radiation (except to bone) or surgery (except exploratory biopsy or intravenous device implantation, etc.) within 28 days prior to study entry.
• Grade 2 or higher sensory neuropathy of any etiology.
• Subjects with severe cardiopulmonary diseases (including history of stable, effort-induced or unstable angina pectoris, myocardial infarction, or arrhythmia) or other systemic diseases under poor control.
• Females who are pregnant, lactating, or have a positive serum pregnancy test except those are diagnosed as germ cell tumor with beta-HCG prior to study treatment. Pre-menopausal women who are not abstinent must prove surgical sterility or compliance with a contraceptive regimen. Male subjects and male partners of female subjects must be abstinent, surgically sterile, or utilizing a barrier contraceptive method.
• Tumor with central nervous system (CNS) involvement.
• Subjects with concomitant active 2nd primary malignancies or disease-free for no more than 3 years following a definitive therapy for prior metachronous malignancies, except for surgically cured carcinoma, i.e. in situ of the cervix or adequately treated basal cell carcinoma of the skin or Dukes' A colorectal cancer.
• Known history of allergy to any component of this investigational preparation.
• History of exposure to SCB01A or its analogs.
• Active infection requiring antibiotic therapy at time of study entry.
• Is unwilling or unable to comply with the protocol requirements.
• Known human immunodeficiency virus (HIV) infection.
• History of receiving organ transplantation or immunologic illness that require continuous immunosuppressant agent therapy.
• Have other medical or psychological conditions that would not permit the study participant to complete the study or sign informed consent.
• Have any other disease, dysfunction, alcohol or drug abuse, physical examination or lab finding that, in the investigator's opinion, would exclude the subject from the study.