Safety and Tolerability Study of SOR-C13 in Subjects With Advanced Cancers Commonly Known to Express the TRPV6 Channel

Inclusion criteria

• Males and females ≥ 18 years of age
• Subjects with a histologic diagnosis of solid tumor cancers of epithelial origin.
• Subjects with advanced refractory cancer for which standard curative or palliative measures do not exist or are no longer effective. There is no limitation on the number or types of prior therapy.
• Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment.
• ECOG (Eastern Cooperative Oncology Group) Performance Score ≤ 1.
• Life expectancy of greater than 12 weeks.

• Subjects must have adequate organ and marrow function as defined below:

  1. hemoglobin ≥9.0 g/dL (≥5.6 mmol/L)
  2. white blood cells ≥3,000/mm³(≥3×10⁹/L)
  3. absolute neutrophil count ≥1,500/mm³ (≥1.5×10⁹/L)
  4. platelets ≥100,000/μL (≥100×10⁹/L)
  5. total bilirubin ≤1.5× upper limit of normal(ULN)
  6. AST/ALT/AP ≤2.5× ULN
  7. creatinine ≤1.5× ULN
  8. albumin ≥3.0 g/dL (≥30 g/L)
  9. INR ≤1.4
• Ability to understand and voluntarily sign the informed consent document

Exclusion Criteria:

• Chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy will not be allowed within either 30 days, or 5 half lives (whichever is longer) prior to study drug administration.
• Subjects with known brain metastases or evidence upon physical/neurological examination of other central nervous system disease (unrelated to cancer).
• Concurrent malignancy other than the solid tumor under investigation, requiring active treatment.
• History of clinically significant allergic reaction attributed to any injected compound.
• History of any of the following cardiovascular events or conditions within the past 6 months prior to enrolment: myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, New York Heart Association Class ≥ II chronic heart failure, hypokalemia, significant arrhythmia; QTc interval >420 msec or use of drugs that prolong the QT interval at screening; family history of long QT syndrome.
• Clinically significant and uncontrolled major medical condition(s) that places the subject at an unacceptably high risk for toxicities. These include, but are not limited to: active infections, symptomatic pulmonary disease, inadequate pulmonary function, seizure disorder, psychiatric illness.
• A known diagnosis of human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS), acute or chronic hepatitis B or hepatitis C infection, as determined by medical history.
• Major surgical procedure within 4 weeks prior to enrolment.
• Lactating or pregnant female.
• Females of childbearing potential and males not using adequate birth control.