IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer

Exclusion Criteria

• •1. Has had major surgery or significant traumatic injury within 28 days prior to first dose of study treatment, or diagnostic biopsies within 14 days prior to first dose of study treatment.
• •2. Has received prior systemic anticancer therapy including investigational agents, such as within 14 days or less than 5 half-lives (whichever is shorter) of chemotherapy or targeted therapy, or within 28 days of immunotherapy, prior to first dose of study treatment.
• •3. Has received prior radiotherapy within 14 days prior to first dose of study treatment.
• •4. Has received prior treatment of any FAK inhibitor or prior treatment of PLD.
• •5. Has a known previous or concurrent cancer that is distinct in primary site or histology from current ovarian cancer within 3 years prior to first dose of study treatment, except for curatively treated cancers such as cervical carcinoma in situ.
• •6. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• •7. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases (e.g., congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism) within 6 months before first dose of study treatment, or has any of the following abnormality:
• •* QTc interval \> 480 msec;
• •* Left ventricular ejection fraction (LVEF) \< 50%;
• •* New York Heart Association (NYHA) functional classification ≥ Grade 2；
• •* Clinically significant arrhythmia;
• •* Uncontrolled hypertension;
• •* Other clinically significant heart diseases.
• •8. Has known uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. Note: A small amount of ascites that can only be detected by imaging examination is allowed.
• •9. Has malabsorption syndrome or inability to take oral drugs.
• •10. Has clinically significant gastrointestinal abnormalities including uncontrolled gastrointestinal inflammatory lesions (Crohn's disease, or ulcerative colitis in active) or uncontrolled gastrointestinal bleeding.
• •11. Has an active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.
• •12. Has known human immunodeficiency virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority and/or site.
• •13. Has known active Hepatitis B or Hepatitis C virus infection. Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority and/or site.
• •14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• •15. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
• •16. Known allergy or hypersensitivity to IN10018 or PLD, or their ingredients.
• •17. Has received prior cumulative anthracycline dose of 550 mg/m2 or more.
• •18. Has received systemic treatment of CYP3A4, CYP2D6 or P-gp strong inhibitors/inducers within 14 days prior to the first dose of study treatment, or anticipation of the systemic treatment of these drugs during Treatment Phase.