Late stage malignant tumor patients diagnosed by histology or cytology who have failed standard treatment, are unable to tolerate standard treatment, or are unable to receive standard treatment for other reasons
Conditions
Interventions
Experimental group:LNF1901 monoclonal antibody injection is administered intravenously once every three weeks
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male or female individuals aged 18 or above; 2. Patients with advanced malignant tumors who have been diagnosed by histology or cytology and have failed standard treatment, or cannot tolerate standard treatment, or are unable to receive standard treatment for other reasons; 3. Subjects in the dose expansion stage who have at least one measurable lesion; 4. Those who score 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) physical Condition assessment system; 5. Researchers determine that the expected survival period of the subjects is greater than or equal to 3 months; 6. The functions of vital organs meet the following requirements (no blood component or cytokine drugs are allowed to be used within 14 days before the first administration) : Blood routine: Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count >=80×10^9/L; Hemoglobin (Hb) >=90g/L; Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) 1.5×ULN); Coagulation function: International normalized ratio (INR) <=1.5×ULN and activated partial thromboplastin time (APTT) <=1.5×ULN; Thyroid function: Thyroid stimulating hormone (TSH) within the normal range or free triiodothyronine (FT3) and free thyroxine (FT4) normal or abnormal have no clinical significance. 7. The subjects voluntarily participated in this study after obtaining full informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Those who have previously received treatment with any tumor necrosis factor receptor (TNFR) superfamily agonist antibodies, such as CD40, OX40, CD137, CD27, CD357 antibodies, etc. 2. Those who have received anti-tumor treatment within 4 weeks before the first administration or within 5 half-lives of the drug (whichever is shorter); 3. Those who have received chronic systemic glucocorticoid therapy (with a daily dose equivalent to prednisone >10mg of systemic corticosteroids) or any other form of immunosuppressive therapy within 2 weeks before the first administration; 4. Those whose previous anti-tumor treatment toxicity has not recovered to grade =4 weeks can be enrolled. 7. Those with a history of organ transplantation or allogeneic bone marrow transplantation, or those who have received autologous stem cell transplantation within 3 months prior to the first administration; 8. Those who have undergone major surgery or have not yet recovered from surgery within 4 weeks prior to the first administration (excluding diagnostic surgery); 9. If any of the following conditions are found during physical examination or laboratory tests: Hepatitis B: positive for HBsAg and/or positive for HBcAb, and the HBV-DNA titer is positive or higher than the upper limit of the normal value (if only the lower limit of detection is available, higher than the lower limit of detection is excluded); Hepatitis C: HCV antibody positive, and HCV-RNA positive or greater than the upper limit of normal value; Positive for human immunodeficiency virus antibody (Anti-HIV) Active Treponema pallidum infection 10. Patients with uncontrollable or severe cardiovascular diseases, such as New York Heart Association (NYHA) grade II or above congestive heart failure, unstable angina pectoris, myocardial infarction and other cardiovascular diseases within 6 months before the first administration, and poorly controlled arrhythmias Uncontrolled hypertension (systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg after adequate treatment); 11. Patients with the following past medical histories, including but not limited to active autoimmune diseases, active infections (such as active pulmonary tuberculosis), severe mental disorders and severe endocrine diseases; 12. Those who have received any other clinical trial drug/device treatment within 4 weeks prior to the first administration; 13. Those who have a history of drug abuse or alcoholism within 6 months prior to the first administration; 14. Those with a history of severe allergies, known to have been allergic to macromolecular protein preparations/monoclonal antibodies and any components of investigational drugs in the past; 15. Those who received live vaccines or attenuated live vaccines within 4 weeks before the first administration, or those who planned to receive live vaccines or attenuated live vaccines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic index;Therapeutic index;Immunogenicity indicators;Receptor space-occupying indicators;Biomarker; | — |
Countries
China
Contacts
Public ContactRuihua Xu
Sun Yat-sen University Cancer Center
Outcome results
None listed