Advanced Solid Tumors
Conditions
Keywords
1197, IDX-1197, venadaparib
Brief 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).
Detailed description
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.
Interventions
DRUGNOV140101 (IDX-1197)
The dose levels will be escalated following a 3+3 dose escalation scheme.
Sponsors
Idience Co., Ltd.
IlDong Pharmaceutical Co Ltd
National OncoVenture
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicities (DLTs) | Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21) |
Countries
South Korea
Outcome results
None listed