Study of Suvemcitug Plus Chemotherapy in Advanced High-Grade Serous Ovarian Cancer

Korábbi kezelés

• Diagnosis of any other malignancy within 3 years prior to enrollment, except for carcinoma in situ (e.g., carcinoma in situ of the breast, bladder, or cervix) or basal cell or squamous cell carcinoma of the skin that has been treated with potentially curative therapy.

Más betegség

• Known hypersensitivity to any study drug or any of its components.
• Active infection requiring systemic therapy.
• Active ulcer, gastrointestinal perforation, or intestinal obstruction.
• Active bleeding or a bleeding tendency.
• Hypertension that is inadequately controlled despite antihypertensive therapy, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
• Active hepatitis, defined as follows:
  • Hepatitis B: positive hepatitis B surface antigen (HBsAg) and HBV DNA ≥500 IU/mL or ≥1,000 copies/mL;
  • Hepatitis C: positive hepatitis C virus (HCV) antibody with an HCV viral load above the upper limit of normal.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Positive for human immunodeficiency virus (HIV).

Laborértékek

• A history of severe cardiovascular or cerebrovascular disease, including any of the following:
  • Cerebrovascular accident (excluding lacunar cerebral infarction, minor cerebral ischemia, or transient ischemic attack), myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the first dose of study treatment;
  • Corrected QT (QTc) interval ≥450 ms in males or ≥470 ms in females, calculated using Fridericia's formula;
  • New York Heart Association (NYHA) functional class \>II; or
  • Left ventricular ejection fraction (LVEF) \<50%.
• Any clinical or laboratory abnormality, or any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical study.

Egyéb

• Histopathologically confirmed mucinous adenocarcinoma or low-grade serous carcinoma.
• Urine dipstick protein ≥2+ with confirmed 24-hour urinary protein excretion \>1.0 g.
• Confirmed or suspected symptomatic brain metastases.

• Subjects voluntarily participate in the study, provide written informed consent, and are able to comply with the study requirements.
• Histologically confirmed primary high-grade serous ovarian cancer (HGSOC) and receipt of primary cytoreductive surgery.
• Age ≥18 years.
• FIGO stage III-IV disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• KELIM value \<1.
• Life expectancy \>3 months.
• Adequate major organ function, as defined by all of the following criteria: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; platelet count ≥80 × 10⁹/L; hemoglobin ≥80 g/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 × the upper limit of normal (ULN); total bilirubin \<1.5 × ULN; and serum creatinine \<1.5 × ULN.