Phase I, Open-label, Dose Escalation Study to Assess Safety and Tolerability of SOR-C13 in Subjects With Advanced Solid Tumors Commonly Known to Express the TRPV6 Ion Channel
- 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
- 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.
- History or clinical evidence of central nervous system (CNS) tumor involvement
(metastases) or other known clinically relevant CNS pathology (e.g., epilepsy,
seizure, paresis, aphasia, cerebellar disease, severe brain injury, psychosis).
- Concurrent malignancy other than the solid tumor under investigation, requiring
- History of clinically significant allergic reaction attributed to any injected
- 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 >430 msec or use of
drugs that prolong the QT interval at screening; family history of long QT
syndrome.(* Significant arrhythmias are defined as symptoms of syncope or severe
palpitations (palpitations requiring referral to cardiac monitoring), or ECG findings
of supraventricular tachycardia (including ventricular fibrillation) or ventricular
ectopy (ventricular premature depolarization).
- 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.
- Current use of more than one antihypertensive medication.
- For patients receiving antihypertensive medication:systolic blood pressure < 120 mmHg
and/or diastolic blood pressure < 70 mmHg at screening.
- 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.
- Current treatment or treatment within 4 weeks of screening with bisphosphonates.