A Study of DXC014 in Patients With Advanced Solid Tumors.

Exclusion Criteria

• •1. Within 14 days prior to the first dose: Underwent plasmapheresis; received systemic corticosteroid therapy at a dose \>10 mg/day prednisone or equivalent for more than 3 consecutive days, or other anti-inflammatory drugs with equivalent activity (short-term use for preventing contrast agent allergy is allowed for enrollment).
• •2. Received systemic anti-tumor therapy or investigational drug treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; received palliative radiotherapy within 14 days prior to the first dose; received treatment with Chinese patent medicines or herbal medicines explicitly indicated for anti-tumor purposes in the NMPA-approved drug label within 1 week prior to the first dose.
• •3. History of solid organ transplantation.
• •4. Prostate Cancer: Leptomeningeal metastasis or brain metastasis. Other Solid Tumors: Participants with active central nervous system (CNS) metastases and/or leptomeningeal metastases or spinal cord compression, with the following exceptions: asymptomatic and stable brain metastases, or participants who have received treatment for brain metastases with no evidence of new or enlarging brain metastases on imaging for at least 4 weeks and no related symptoms, and who have discontinued steroid or anticonvulsant therapy for at least 14 days prior to initiation of study treatment.
• •5. Evidence of cardiovascular risk, including any of the following: a. QTcF interval ≥ 470 milliseconds (QT interval must be corrected using Fridericia's formula \[QTcF\]). b. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd-degree (Mobitz Type II) or 3rd-degree atrioventricular block. c. History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, stenting, or bypass grafting within 6 months prior to screening. d. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. e. Uncontrolled severe hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• •6. Uncontrolled diabetes mellitus.
• •7. Current interstitial lung disease or pulmonary fibrosis, pneumoconiosis, radiation pneumonitis, severely impaired pulmonary function, or other conditions that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
• •8. History of or current other malignancies within the past 5 years. Participants may be enrolled in the following two scenarios: other malignancies treated with single surgery alone, achieving continuous 5-year disease-free survival (DFS); adequately treated carcinoma in situ with no evidence of recurrence, such as cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\].
• •9. Presence of severe unhealed wounds, ulcers, or fractures; major surgery within 28 days prior to the first dose or anticipated major surgery during the clinical study period.
• •10. History of allergy to any component or excipient of DXC014 .
• •11. Active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL or above the upper limit of normal \[ULN\] of the testing unit); active hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection).
• •12. Known positive HIV serology; active syphilis (participants with only a positive syphilis antibody test may be enrolled); suspected active tuberculosis (chest imaging within 3 months prior to the first dose suggests active tuberculosis infection).
• •13. Active bleeding within 30 days prior to screening, or judged by the investigator to be at risk of major gastrointestinal bleeding, hemoptysis, etc.; or hereditary bleeding tendency or coagulation dysfunction; or hemorrhagic symptoms requiring other medical intervention.
• •14. History of severe arterial/venous thrombotic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism.
• •15. Female participants who are pregnant (positive serum pregnancy test) or breastfeeding.
• •16. Active infection requiring systemic medication (CTCAE ≥ Grade 2) within 2 weeks prior to the first dose of study treatment; uncontrolled pleural effusion, ascites, or pericardial effusion requiring repeated drainage.
• •17. Administration of a live attenuated vaccine within 28 days prior to the first dose or planned vaccination during the study period.
• •18. Any other condition that, in the judgment of the investigator or sponsor, may affect the participant's participation in this study.