Study to Assess the Safety & Tolerability of NOV140101(IDX-1197) in Patients With Advanced Solid Tumors

Open-label, Phase I Clinical Trial to Identify Optimal Dose and Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Anti-cancer Efficacy of NOV140101(IDX-1197HCl) in Patients With Advanced Solid Tumors

the purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV140101 (IDX-1197).

This is an open-label, Phase 1 dose escalation study of NOV140101 (IDX-1197) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of IDX-1197 in patients with advanced solid tumors after failure of standard of care. DLTs will be assessed as the primary endpoint in this trial.

Inclusion Criteria:

• ≥19 year old patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors

• Life expectancy ≥12 weeks

• Women of childbearing potential must have a negative pregnancy test outcome

• ECOG performance status ≤2

• Lesions measured by tumor markers or CT/MRI and evaluable according to RECIST v1.1

• Patient must have adequate organ function as indicated by the following laboratory values independent of transfusion within 2 weeks:

  1. ANC ≥ 1,500/mm³
  2. Platelet count ≥ 100,000/mm³
  3. Hemoglobin ≥ 9.0g/dL
  4. Serum creatinine ≤ 1.5×ULN
  5. Total bilirubin ≤ 1.5×ULN
  6. AST, ALT ≤ 3×ULN (≤ 5×ULN for patients with liver metastasis or liver cell cancer)
  7. PT and aPTT ≤ 1.5×ULN
  8. UPC < 1.0 g/g (one re-test is allowed if positive (≥ 1))

• Patients must provide written informed consent to voluntary participation in this study.

Exclusion Criteria:

• History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class
• New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled hypertension (systolic/diastolic blood pressure >140/90mmHg), or other clinically significant cardiovascular abnormalities in the opinion of the investigator
• Uncontrolled cardiac arrhythmia
• Acute coronary syndrome (unstable angina pectoris or myocardial infarction) within the past 6 months
• Major electrocardiogram (ECG) abnormalities in the opinion of the investigator
• Severe infection or severe traumatism
• Pneumonia or respiratory symptoms, such as dyspnea, cough, and fever, requiring treatment and other conditions likely to be accompanied by hypoxemia
• History of drug or alcohol abuse within the past 3 months
• Symptomatic or uncontrolled central nervous system (CNS) metastasis
• Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a minor surgery
• Radiotherapy, hormone therapy, or chemotherapy within 2 weeks prior to baseline from which toxicities not recovered to ≤grade 1
• >4 weeks of persistent Grade 3 (NCI-CTCAE v4.03) hematologic toxicities from prior anticancer treatment
• History of myelodysplastic syndrome (MDS) or pre-treatment cytogenetic test results indicative of the risk of MDS or acute myelocytic leukemia
• Ongoing or anticipated treatment with antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, etc.) during the study
• Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
• Ongoing or past treatment with immunosuppressants within 14 days prior to the first dose of study treatment, except for intranasal, inhaled, topical, or locally injected (e.g., intraarticular injection) steroids
• History of serious gastrointestinal bleedings within 12 weeks prior to screening or presence of diseases that may affect oral drug absorption (e.g., malabsorption syndrome, active peptic ulcer)
• History of human immunodeficiency virus infection or active hepatitis B or C infection or ongoing uncontrolled chronic infectious disease
• Pregnant or lactating women or patients planning to become pregnant during the study
• Participation in another clinical trial within 30 days prior to screening
• Individual considered ineligible for this study for other reasons, in the opinion of the investigator