Advanced solid tumor
Conditions
Interventions
Experimental group:About 250 mL sterile saline (0.9% sodium chloride solution) was used to dilute the total dose to be administered (calculated according to the subject's body weight and dose group),
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical research; Fully understand and be informed of the study and sign the ICF; Willing to follow and able to complete all test procedures. 2. Age: =18 years old (osteosarcoma and soft tissue sarcoma subjects =14 years old) for both men and women. 3. Enrolled subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors (unresectable), failure of standard therapy, absence of standard therapy, or refusal of standard therapy: 4. Subjects with ECOG score of physical status 0 or 1. 5. According to RECIST v1.1 (Solid tumors), the subject has at least one measurable or evaluable lesion that has not previously been locally treated [bone only or central nervous system (CNS) only metastases are not accepted as measurable lesions]; 6. At least 3 months of expected survival, safety and effectiveness data can be followed up. 7. Participants who have received antitumor therapy in the past should not be admitted until toxicity from previous therapy has returned to baseline (except for residual alopecia effects) or CTCAE v5.0 score = Class 1. 8. Adequate organ and bone marrow function, no severe hematopoietic dysfunction, abnormal heart, lung, liver, kidney function, and immune deficiency (no blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support within 14 days prior to use of the investigatory drug). : a) ANC = 1.5×10^9 /L; b) Platelet = 100×10^9 /L; Stage Ib: For HCC subjects, platelets = 80×10^9 /L; c) Hemoglobin = 9 g/dL; d) Serum creatinine = 1.5 times the upper limit of normal (ULN), creatinine clearance > 60 mL/min (as estimated by the Cockcroft-Gault formula) can be included in the group (note: creatinine clearance needs to be confirmed only when serum creatinine is higher than 1.5 times the upper limit of the reference range of normal); e) Serum total bilirubin = 1.5 times ULN; f) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times ULN; For liver cancer or liver metastasis subjects, AST and ALT = 5 times ULN; g) International Standardized Ratio (INR) or plasma prothrombin time (PT) = 1.5 times ULN. 9. Female subjects of reproductive age or male subjects and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose of the study drug
Exclusion criteria
Exclusion criteria: 1. Subjects with known primary CNS tumors, or meningeal metastases, or unstable CNS metastases (having symptoms in the 4 weeks prior to initiation of study therapy, requiring hormone therapy, or without imaging evidence that the lesion is stable for more than 4 weeks). 2. Subjects with active or past autoimmune diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vaslitis, psoriasis, etc.) or at risk (e.g., organ transplant requiring immunosuppressive therapy). However, subjects with type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) are allowed to be further screened. 3. Subjects who required treatment with glucocorticoids (prednisone > 10 mg/ day or equivalent doses of other similar drugs) or other immunosuppressants for a condition within 14 days prior to study drug administration. Note: In the absence of active autoimmune disease, prednisone or an equivalent adrenal drug dose = 10 mg/ day is allowed to substitute administration; Subjects were allowed to use topical, ocular, intraarticular, intranasal, and inhaled corticosteroids (with very low systemic absorption); Short-term (= 7 days) use of glucocorticoids is permitted for preventive treatment (e.g., contrast agent allergy) or for treatment of non-autoimmune diseases (e.g., delayed hypersensitivity due to contact allergens). 4. Received systemic antitumor therapy, including chemotherapy, immunotherapy, biotherapy (tumor vaccine, cytokines, or growth factors to control cancer), 14 days before starting the study treatment. 5. Major surgery, or radical radiotherapy within the first 28 days, or palliative radiotherapy within the first 14 days, or radiation agents (strontium, samarium, etc.) within 56 days prior to the start of the study. 6. Chinese herbal medicine or proprietary Chinese medicine that has received anti-tumor indications within 7 days before starting the study treatment. 7. Have had interstitial lung disease, chemical pneumonia, hypersensitivity pneumonia, connective tissue disease pneumonia, pulmonary fibrosis, acute lung disease, etc. (except local interstitial pneumonia induced by radiotherapy), or uncontrolled systemic diseases, including diabetes, hypertension, etc. 8. Subjects with a known history of human immunodeficiency virus (HIV) infection. 9. Subjects with chronic hepatitis B or active hepatitis C. Subjects who are positive for Hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening stage must be further tested by hepatitis B virus (HBV) DNA titers (no more than 1000 copies [cps]/mL or 200 IU/mL) and HCV RNA tests (exceeding the lower detection limit of the assay). Inclusion in the trial was only possible after the exclusion of an active hepatitis B or C infection requiring treatment. Hepatitis B carriers, patients with stable hepatitis B after drug treatment (DNA titers not higher than 1000 copies [cps]/mL or 200 IU/mL), and cured hepatitis C subjects were eligible for admission. 10. Subjects with active pulmonary tuberculosis. 11. Any active infection that requires systemic systemic treatment occurs within 2 weeks prior to initiation of study therapy. 12. Subjects who have received solid organ transplants. 13. Subjects who have received immunotherapy and developed irAE grade = 3. 14. Subjects with known severe aller
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety ;Tolerability;Maximum tolerated dose;Recommended phase II dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) characteristics;Antitumor effect;Immunogenicity; | — |
Countries
China
Contacts
Public ContactZan Shen
Shanghai Sixth People's Hospital
Outcome results
None listed