Cancer
Conditions
Interventions
Sponsors
Shanghai Sixth People‘s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily act as a participant, and sign an informed consent form before commencing any procedure; 2. Age 18~75(including boundary values), male or female; 3. Patients with advanced malignant solid tumors who have been confirmed by histology or cytology and do not currently have a standard treatment regimen or are ineffective to standard therapy (disease progression after treatment or treatment intolerance), including but not limited to: bone and soft tissue sarcoma; 4. At least 1 measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST V1.1)(CT scan or MRI no more than 4 weeks prior to ICF signing); 5. At least 1 injectable lesions (can be injected directly or assisted by medical imaging instruments); 6. ECOG 0~1; 7. Expected survival >=3 months 8. Adequate organ and bone marrow function within 7 days prior to the first dose: a. Haematology: platelets (PLT) = 80 × 109/L, neutrophil count (ANC) = 1.5 × 109/L, hemoglobin = 9 g/dL (no adjunctive means such as EPO, G-CSF or GM-CSF in the 14 days prior to the first dose, and no blood transfusion for at least 7 days); b. Coagulation function: INR = 1.5, APTT = 1.5 × ULN (upper limit of normal), PT = 1.5× ULN; c. Liver function: total bilirubin = 1.5 × ULN (total bilirubin =3 ×ULN can be enrolled in patients with Gilbert syndrome), AST and ALT = 3 × ULN (if liver metastases, AST, ALT = 5 × ULN); d. Renal function: serum creatinine = 1.5× ULN or creatinine clearance = 50 mL/min (according to the Cockcroft-Gault formula); e. Cardiac function: QT interval (QTcF) = 470 ms in women and = 450 ms in men. 9. Be able to communicate well with the investigator and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Pregnant (positive pregnancy test before medication) or breastfeeding women; 2. A history of severe allergy to excipients of the investigational drug 3. Received any investigational drug within 28 days prior to initial dosing 4. Have anti-tumor therapy within 28 days before the first dose, including radiotherapy (except palliative radiotherapy), chemotherapy, biological therapy, endocrine therapy and immunotherapy, small molecule targeted drugs can be counted as 5 half-life discontinuations, the antitumor effect of Chinese herbal medicines for more than 14 days, subjects receiving the combination drug can be enrolled after the end of the 5-fold half-life of the longer half-life drug; 5. Have undergone surgery or interventional therapy (excluding tumor biopsy, puncture, etc.) within 28 days prior to initial administration, or wounds, ulcers, fractures that have not healed; 6. Patients who are received systemic corticosteroids or other immunosuppressive drugs within 28 days prior to initial administration or on antivirals; 7. Subjects with clinical symptoms of brain metastasis, spinal cord compression, cancerous meningitis, or other evidence of uncontrolled brain or spinal cord metastasis. 8. Clinically evident and/or rapidly accumulating ascites, pericardial and/or pleural effusion; 9. Severe cardiovascular disease, including but not limited to: a. Have severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.; b. According to the standards of the New York Heart Association (NYHA), grade III~IV cardiac insufficiency; c. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or greater cardiovascular and cerebrovascular events within 6 months prior to first dose; d. Clinically uncontrolled hypertension (BP < systolic blood pressure 140 mmHg and diastolic blood pressure < 90 mmHg despite standard antihypertensive therapy) 10. The adverse reactions of previous anti-tumor treatment could not be recovered to NCI CTCAE v5.0 level =1 (except for toxicity without safety risk as determined by researchers, such as hair loss). 11. Patients who are uncontrollable or have severe illness, including but not limited to persistent or active infections, who require antibiotic therapy; 12. Previous history of immunodeficiency, including other acquired or congenital immunodeficiency disorders, or a history of organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation; 13. History of exfoliative skin requiring systemic treatment (e.g., eczema or atopic dermatitis) 14. Human immunodeficiency virus (HIV) antibody positive patients; 15. Patients with active hepatitis B (HBV)/hepatitis C (HCV) infection [prior history of hepatitis C but negative HCV RNA during screening; HBsAg positive but HBV DNA < 500 IU/ml or HBV DNA below the lower limit of the center test can be enrolled (primary liver cancer subjects with HBV DNA <1000 IU/ml can be enrolled)]; 16. Men and women who were reluctant to use appropriate methods of contraception throughout during the study period (simultaneous use of spermicides, barrier contraceptives, and/or intrauterine contraceptives, etc.); 17. Patients with psychiatric disorders or disorders that may affect trial adherence; 18. Patients who may require antineoplastic therapy other than the investigational AYK103 injection 19. Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose ;Dose-limiting toxicity;Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| cytokines;Immune cells; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Shanghai Sixth People‘s Hospital
Outcome results
None listed