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

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 fluorouracil or small-molecule targeted drugs within 2 weeks or 5 half-lives (whichever is shorter) 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 trial within 4 weeks before the first dose.
• •3. Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks 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 days or 5 half-lives (whichever is shorter) before the first dose.
• •5. Previous allogeneic hematopoietic stem cell or bone marrow transplantation, or previous solid organ transplantation, or current use of immunosuppressive drugs or anti-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 1 according to CTCAE v5.0 (except for toxicities deemed not to pose a safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or stable hypothyroidism managed with hormone replacement).
• •8. Active hepatitis B (HBsAg positive with HBV-DNA \> lower limit of detection at the study center); hepatitis C virus infection (HCV-RNA \> lower limit of detection at the study center); positive HIV antibody test; positive Treponema pallidum antibody test.
• •9. Presence of brain metastases or leptomeningeal metastases during the screening period or previously.
• •10. Presence of uncontrolled third-space effusions (e.g., large pleural effusions and/or ascites) as judged by the investigator.
• •11. Severe cardiovascular diseases, including but not limited to:
• •Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.
• •Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular events within 6 months before the first dose.
• •New York Heart Association (NYHA) functional class ≥II, or other high-risk structural heart diseases as judged by the investigator.
• •Uncontrolled hypertension clinically (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after treatment).
• •Any factors increasing the risk of QTc prolongation or arrhythmias, such as heart failure, uncorrectable hypokalemia, congenital long QT syndrome, family history of long 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 the first dose.
• •13. Presence of gastrointestinal diseases affecting drug absorption, such as Crohn's disease, ulcerative colitis, or short bowel syndrome, in an acute exacerbation phase, which may affect the absorption, metabolism, or elimination of the study drug as judged by the investigator.
• •14. Presence of interstitial lung disease, pulmonary fibrosis, or drug-induced interstitial 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 judged by the investigator.
• •16. Presence of other malignancies within the past 5 years, except for cured basal cell carcinoma 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 the investigator to make the subject unsuitable for participation in the study.