study to assess the safety & tolerability of nov140101(idx-1197) in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: 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.

Eligibility criteria:
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

Keywords: 1197 idx-1197 venadaparib