Clinical Research Directory

Inclusion Criteria: * Age ≥ 18 years * Malignant solid tumors confirmed by histology or cytology * Failure of standard treatment or intolerable toxicity, or no standard treatment (Phase Ia) * At least one measurable lesion meeting RECIST 1.1 criteria at baseline (the measurable lesion area has not received previous radiotherapy, or there is evidence that the lesion has clearly progressed after the end of radiotherapy) (only applicable to dose expansion) * ECOG PS score 0-1 * Expected survival period ≥ 3 months * Adequate organ function, meeting the following criteria within 7 days before the first administration: Hematology (without blood transfusion, EPO, G-CSF within 14 days prior to the first administration): absolute neutrophil count ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Hemoglobin ≥ 90 g/L; Liver function: total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome); Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases); Renal function: serum creatinine ≤ 1.5 × ULN. When serum creatinine \> 1.5 × ULN, creatinine clearance (Ccr) should be calculated according to Cockcroft-Gault formula and be ≥ 60 ml/min; Coagulation (without anticoagulant therapy): prothrombin time or international normalized ratio ≤ 1.5 × ULN. -Participants must give informed consent to this study before the trial and voluntarily sign a written informed consent form. Exclusion Criteria: * Subjects with a history of severe allergies; Known hypersensitivity or intolerance to any component of the vaccine or its excipients; * Subjects with central nervous system metastasis or meningeal metastasis. Patients who have undergone targeted radiotherapy or surgical treatment and have no clinical symptoms and signs without drug symptomatic treatment can be enrolled; * Subjects with tumor invasion of important arteries leading to high risk of bleeding, obvious risk of perforation, or fistula formation; * Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage; * Adverse events of previous anti-tumor treatment (including radiotherapy) have not recovered to CTCAE 6.0 ≤ Grade 1 (except for some toxicities such as alopecia and fatigue that are judged by the investigator to have no safety risk); * Diagnosed with a second primary malignant tumor within 5 years before the first administration of the study drug; Except for effectively treated basal cell carcinoma of skin, squamous cell carcinoma of skin, and/or effectively resected cervical cancer and/or breast cancer in situ; * Received chemotherapy, biological therapy, targeted therapy and other anti-tumor treatments within 21 days before the first administration of the study drug, among which: oral small molecule targeted drugs are within 14 days before the first dose of the study drug or within 5 half-lives of known drugs (whichever is longer); Radiotherapy within 14 days prior to the first administration of study drug; Traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 7 days before the first administration of the study drug; * Received live or live-attenuated vaccines within 28 days prior to the first administration of study drug or planned to receive during the study; * Received palliative treatment for local lesions (including local radiotherapy or other local treatments) within 14 days before the first administration of the study drug; * Have undergone major surgery (excluding puncture biopsy) or severe traumatic injury 28 days before the first administration of the study drug; * Subjects with a history of severe cardiovascular disease, including but not limited to: 1. Baseline complete left bundle branch block or third-degree atrioventricular block; 2. Baseline unstable angina and myocardial infarction within 6 months; 3. Prolonged QT/QTc interval at baseline (QTcF \> 450 ms for males and \> 480 ms for females); 4. Severe arrhythmia at baseline, which is judged by the investigator to have an impact on this trial; 5. Left ventricular ejection fraction ≤ 50% by baseline echocardiography or multi-gated acquisition technique; 6. Baseline heart failure, NYHA class II or above; 7. Baseline poorly controlled hypertension (blood pressure greater than or equal to 160/110 mmHg despite optimal therapy); 8. Previous or current cardiomyopathy that, in the opinion of the investigator, has an impact on this trial. * History of autoimmune diseases (except for psoriasis/alopecia/vitiligo that does not require systemic treatment and is in stable condition in the past year, type 1 diabetes mellitus that uses stable doses and has stable blood sugar control, subclinical hypothyroidism, hypothyroidism that does not require hormone replacement therapy or is in stable condition after hormone replacement therapy, and other diseases suitable judged by the investigator); * History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or organ transplantation; * Infectious diseases requiring systemic anti-infective (such as antibiotics, antiviral or antifungal drugs) treatment (except those with controllable infection-related risks after administration of the study drug judged by the investigator); * Active hepatitis B (hepatitis B virus DNA assay \> 1000 copies/mL or 200 IU/mL); Hepatitis C infection (hepatitis C antibody positive and HCV-RNA above the lower limit of detection at the study site); Active syphilis infection, active tuberculosis; * Lactating or pregnant women; Women of childbearing potential have a positive blood pregnancy test within 7 days prior to trial enrollment; \[A participant is of childbearing potential (judged by the investigator) when he/she is biologically capable of fathering a child and is sexually active. Female participants who are not of childbearing potential (i.e., meet at least 1 of the following criteria): have had a hysterectomy or bilateral oophorectomy, or have medically confirmed ovarian failure, or are medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months without a pathological or physiological cause).\] * Any male and female participants of childbearing potential who refuse to use effective contraceptive methods throughout the trial and within half a year after the last dose; * Other conditions that the investigator believes will affect the safety or compliance of the study drug treatment, including but not limited to: mental illness, any severe or uncontrolled disease, etc.