A Study of DC05F01 in Chinese Patients with Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors

Inclusion Criteria:

1. Voluntarily signed the informed consent form, understanding the study and willing tofollow and capable of completing all trial procedures.

2. Aged ≥18 years, regardless of gender.

3. Patients with locally advanced or metastatic disease, including: Cohort 1: Epithelial ovarian cancer, fallopian tube cancer, or primary peritonealcancer with FIGO stage III-IV, previously treated with platinum-based therapy andexperienced disease progression or recurrence during or within 6 months (184calendar days) after the last platinum-based treatment. Cohort 2: Limited-stage small cell lung cancer patients, as staged by the VeteransAdministration Lung Study Group (VALG), who are not surgical candidates and have notprogressed during or after at least 4 cycles of platinum-based chemotherapy combinedwith concurrent or sequential radiotherapy, completed within 6 weeks before thefirst dose. Cohort 3: Other solid tumors that have failed standard treatment, have no standardtreatment options, or for whom standard treatment is not applicable at present.

4. Cohort 1: Patients must have undergone initial or interval debulking surgery.Elevated CA125 alone without radiological or clinical evidence cannot be consideredas disease progression or recurrence. Prior treatment may include bevacizumab andPARP inhibitors. Cohort 2: Chemotherapy regimens must include platinum agents and intravenousetoposide, followed by a radical radiotherapy regimen. Prophylactic cranialirradiation is allowed based on the investigator's judgment and local standard ofcare, completed within 6 weeks before the first dose.

5. According to RECIST 1.1 criteria, there must be at least one measurable lesionassessed by imaging (lesions within previously irradiated areas or treated withother local therapies are generally not considered measurable unless there isdocumented progression) (applicable to Cohort 1 and Cohort 3).

6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.

7. Expected survival time of ≥3 months.

8. No significant hematologic, hepatic, renal, coagulation, or cardiac functionabnormalities. Laboratory test results during the screening period (no transfusionsor hematopoietic growth factor support within 14 days before testing) must meet thefollowing 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. Serumsodium, potassium, magnesium, calcium, and phosphate levels within normal range ordeemed clinically insignificant by the investigator. Supplements to maintain normalelectrolyte levels are permitted.

9. Male subjects and women of childbearing potential must agree to use effectivecontraception from the time of signing the informed consent form until 3 monthsafter the last dose of the study drug. Women of childbearing potential must have anegative serum pregnancy test prior to the first dose of the study drug.

Exclusion Criteria:

1. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy,immunotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, except for: Nitrosoureas or mitomycin C within 6 weeks before the first dose. Oral fluorouracilor small-molecule targeted drugs within 2 weeks or 5 half-lives (whichever isshorter) before the first dose. Anti-tumor traditional Chinese medicine within 2 weeks before the first dose.

2. Received any other investigational drug or treatment in another clinical trialwithin 4 weeks before the first dose.

3. Underwent major organ surgery (excluding biopsy) or significant trauma within 4weeks before the first dose, or requires elective surgery during the trial period.

4. Used strong inhibitors or inducers of CYP3A4, CYP1A2, and/or CYP2D6 within 14 daysor 5 half-lives (whichever is shorter) before the first dose.

5. Previous allogeneic hematopoietic stem cell or bone marrow transplantation, orprevious solid organ transplantation, or current use of immunosuppressive drugs oranti-rejection medications.

6. Allergy to any active or inactive ingredient of the study drug.

7. Adverse effects from prior anti-tumor treatments have not resolved to ≤Grade 1according to CTCAE v5.0 (except for toxicities deemed not to pose a safety risk bythe investigator, such as alopecia, Grade 2 peripheral neuropathy, or stablehypothyroidism managed with hormone replacement).

8. Active hepatitis B (HBsAg positive with HBV-DNA > lower limit of detection at thestudy center); hepatitis C virus infection (HCV-RNA > lower limit of detection atthe study center); positive HIV antibody test; positive Treponema pallidum antibodytest.

9. Presence of brain metastases or leptomeningeal metastases during the screeningperiod or previously.

10. Presence of uncontrolled third-space effusions (e.g., large pleural effusions and/orascites) as judged by the investigator.

11. Severe cardiovascular diseases, including but not limited to: Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmiasrequiring clinical intervention, II-III degree atrioventricular block, etc. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, orother Grade 3 or higher cardiovascular events within 6 months before the first dose. New York Heart Association (NYHA) functional class ≥II, or other high-riskstructural heart diseases as judged by the investigator. Uncontrolled hypertension clinically (systolic blood pressure ≥140 mmHg and/ordiastolic blood pressure ≥90 mmHg after treatment). Any factors increasing the risk of QTc prolongation or arrhythmias, such as heartfailure, uncorrectable hypokalemia, congenital long QT syndrome, family history oflong QT syndrome, or use of any concomitant drugs known to prolong the QT interval.

12. Presence of active infections requiring systemic treatment within 4 weeks before thefirst dose.

13. Presence of gastrointestinal diseases affecting drug absorption, such as Crohn'sdisease, ulcerative colitis, or short bowel syndrome, in an acute exacerbationphase, which may affect the absorption, metabolism, or elimination of the study drugas judged by the investigator.

14. Presence of interstitial lung disease, pulmonary fibrosis, or drug-inducedinterstitial pneumonia, except for radiation-induced pneumonia.

15. Presence of other severe diseases, including liver disease, kidney disease,neurological/psychiatric disorders, endocrine system diseases, hematologic diseases,immune system diseases, etc., that may affect participation in the study as judgedby the investigator.

16. Presence of other malignancies within the past 5 years, except for cured basal cellcarcinoma of the skin, non-melanoma skin cancer, or in situ cervical cancer.

17. Known alcohol or drug dependence.

18. Presence of psychiatric disorders or poor compliance.

19. Pregnant or breastfeeding women.

20. Any other clinical or laboratory abnormalities or other reasons deemed by theinvestigator to make the subject unsuitable for participation in the study.