Patients with advanced solid tumors
Conditions
Interventions
YKYY031 group (the first stage):Eligible participants selected through screening will be sequentially assigned to dose groups A1 to A6 (in ascending order of dose) according to their enrollment sequen
YKYY031 group (the second stage):Based on the results of the dose-escalation trial, 1–2 dose groups will be selected for the dose-expansion trial of YKYY031 for injection as monotherapy or in combinat
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 years =3 months; 6. At least one measurable lesion (longest diameter of non-lymph nodes >=10 mm, shortest diameter of lymph nodes >=15 mm) according to RECIST V1.1 criteria 7. Good function of major organs, that is, relevant examination indicators meet the following requirements: Hemoglobin >=90 g/L, neutrophil count >=1.5×10^9/L, platelet count >=80×10^9/L within 14 days before the first dose of vaccination; Total bilirubin =50 ml/min (Cockcroft-Gault formula); Prothrombin time =50% 8. Female or male participants of childbearing potential have no childbearing, egg donation, or sperm donation plan from the date of signing the informed consent form to 6 months after the last treatment of the study, and must agree to use effective contraception (including one or more non-drug contraceptive measures) or safety measures during this period; 9. Agree to abide by the requirements and procedures of the clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergic to the trial drug (including any excipients). Have a history of severe allergies to any medicine, food, or vaccination, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.; 2. The patient has a history of other tumors, except for malignant tumors that have been cured and have not recurred within 5 years before screening, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ and other malignant tumors that the researcher believes can be included; 3. Those with clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence that the participant's central nervous system metastasis or meningeal metastasis has not been controlled, and who are judged by the researcher to be unsuitable for enrollment. Patients with brain metastases whose disease is stable (no progression within 4 weeks of imaging examination) and who do not require steroid treatment for at least 4 weeks before the first dose of this study can be enrolled; 4. Cardiovascular diseases with significant clinical significance, including but not limited to; a) congestive heart failure (NYHA classification > Level II); b) Myocardial infarction, unstable angina, severe pericardial disease, severe myocardial disease in the past 6 months; c) The presence of cardiac valve regurgitation or stenosis that requires treatment; d) Any supraventricular arrhythmia or ventricular arrhythmia that requires treatment or intervention; the presence of malignant arrhythmias that are poorly controlled by medications; complete left bundle branch block, II or III degree atrioventricular block; e) QT interval (QTcF) in men >450 ms, women >470 ms; f) poorly controlled hypertension (defined as systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg when controlled by 2 or 3 antihypertensive drugs); 5. Any active autoimmune disease or a history of autoimmune disease, including but not limited to immune-related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue diseases, scleroderma, autoimmune hepatitis, toxic epidermal necrolysis or Stevens-Johnson syndrome (except for type I diabetes using stable doses of insulin, hypothyroidism receiving stable hormone replacement therapy, etc.); 6. Have any uncontrollable clinical diseases (for example, diseases of the respiratory system, circulatory system, nervous system, blood system, genitourinary system, endocrine system) or mental diseases (for example, depression, schizophrenia) or other major diseases that the researcher assesses will hinder the provision of informed consent, interfere with the interpretation of trial results, participate in this trial may bring risks to participants, or otherwise affect the realization of the purpose of the trial, including uncontrollable pleural effusion, pericardial effusion, or ascites effusion as judged by the researcher; 7. Patients with a known history of interstitial pneumonia or who are highly suspected of having interstitial pneumonia; or patients with pulmonary abnormalities that may interfere with the detection or processing of suspected drug-related pulmonary toxicity during the trial; 8. Patients with any abnormalities at the vaccinatio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Immunogenicity and immune-related characteristics; | — |
Countries
China
Contacts
Public ContactLin Shen
Beijing Cancer Hospital
Outcome results
None listed