Ovarian Cancer Clinical Trials

• Written informed consent provided prior to any screening procedures.

• Male or female patients, ≥18 years of age at the time of obtaining informed consent.

• Patients with histologically or cytologically confirmed advanced solid tumors previously treated with standard of care systemic therapy, or for whom no standard therapy is available.

• Willingness to provide archival tumor tissue, when available. If no archival tissue is available, willingness to undergo a pretreatment biopsy if medically feasible and safe.

• Measurable disease per RECIST v1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and life expectancy of ≥12 weeks.

• Adequate organ function as defined by:

‣ Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/µL), without colony-stimulating factor support for the past 14 days.

⁃ Platelets ≥100.0 x 109/L (100 000/µL).

⁃ Hemoglobin ≥9.0 g/dL (without blood transfusion in 2-week period prior to screening).

⁃ Creatinine clearance (CrCl) ≥45 mL/min as calculated by the Cockcroft-Gault method.

⁃ Serum total bilirubin ≤ 1.5 x the upper limit of normal (ULN).

⁃ Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤ 2.5 x ULN.

⁃ International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.

⁃ Left ventricular ejection fraction (LVEF) ≥50% as per echocardiography (ECHO) or multi-gated acquisition scan (MUGA).

⁃ Q wave to T wave (QT) interval corrected for heart rate (QTc) ≤480 ms (Fridericia's formula).

⁃ Baseline oxygen saturation on room air ≥ 92%

⁃ Albumin ≥ 3.0 g/dL

• Women of child-bearing potential (WOCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must agree to use a highly effective contraceptive method

• Patients must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements.