Phase Ib/IIa Multicenter, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of DC05F01 in Patients with Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors
This study is a multicenter, open-label, cohort expansion Phase Ib/IIa trial designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of DC05F01 in patients with recurrent/refractory ovarian cancer and other advanced solid tumors.
• Voluntarily signed the informed consent form, understanding the study and willing to follow and capable of completing all trial procedures.
• Aged ≥18 years, regardless of gender.
• Patients with locally advanced or metastatic disease, including:
• Cohort 1: Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with FIGO stage III-IV, previously treated with platinum-based therapy and experienced disease progression or recurrence during or within 6 months (184 calendar days) after the last platinum-based treatment.
• Cohort 2: Limited-stage small cell lung cancer patients, as staged by the Veterans Administration Lung Study Group (VALG), who are not surgical candidates and have not progressed during or after at least 4 cycles of platinum-based chemotherapy combined with concurrent or sequential radiotherapy, completed within 6 weeks before the first dose.
• Cohort 3: Other solid tumors that have failed standard treatment, have no standard treatment options, or for whom standard treatment is not applicable at present.
• Cohort 1: Patients must have undergone initial or interval debulking surgery. Elevated CA125 alone without radiological or clinical evidence cannot be considered as disease progression or recurrence. Prior treatment may include bevacizumab and PARP inhibitors.
• Cohort 2: Chemotherapy regimens must include platinum agents and intravenous etoposide, followed by a radical radiotherapy regimen. Prophylactic cranial irradiation is allowed based on the investigator's judgment and local standard of care, completed within 6 weeks before the first dose.
• According to RECIST 1.1 criteria, there must be at least one measurable lesion assessed by imaging (lesions within previously irradiated areas or treated with other local therapies are generally not considered measurable unless there is documented progression) (applicable to Cohort 1 and Cohort 3).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival time of ≥3 months.
• No significant hematologic, hepatic, renal, coagulation, or cardiac function abnormalities. Laboratory test results during the screening period (no transfusions or hematopoietic growth factor support within 14 days before testing) must meet the following standards:
• Absolute Neutrophil Count (ANC) \>1.5×10\^9/L. Hemoglobin (HGB) ≥90 g/L. Platelets (PLT) \>100×10\^9/L. Total Bilirubin (TBIL) ≤1.5 mg/dL. Albumin (ALB): ≥3 g/dL. Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT)/Alkaline Phosphatase (ALP)/Gamma-Glutamyl Transferase (GGT) ≤2.5 times the upper limit of normal (ULN). If liver metastases are present, AST/ALT/ALP \< 5×ULN.
• Serum Creatinine (Scr) ≤1.5×ULN or Creatinine Clearance (CrCl) ≥60 mL/min. Prothrombin Time (PT)/Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN. Serum sodium, potassium, magnesium, calcium, and phosphate levels within normal range or deemed clinically insignificant by the investigator. Supplements to maintain normal electrolyte levels are permitted.
• Male subjects and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of the study drug.