Advanced malignant solid tumor
Conditions
Interventions
group1:0.02mg/kg
group2:0.2mg/kg
group3:1mg/kg
group4:5mg/kg
group5:10mg/kg
group6:15mg/kg
group7:20mg/kg
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Patients with histologically or cytologically confirmed local recurrent or metastatic solid tumors who have failed standard treatment, or have no standard treatment, or are currently not eligible for standard treatment, or cannot tolerate standard treatment; 3. According to RECISIT1.1, there is at least one measurable tumor lesion for each patient; 4 Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 5. Life expectancy of greater than 3 months; 6. Adequate organ function: hematological system (no blood transfusion or hematopoietic stimulator therapy within 14 days): Absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelet count (PLT)>= 75x10^9/L, hemoglobin (Hb) >=90g/L; Hepatic function: total bilirubin (TBIL) 45ml/min by the Cockcroft-Gault formula; Coagulation function: Activated partial thrombin time (APTT) <=1.5 ULN, international standardized ratio (INR) <=1.5 ULN; Others Lipase <=1.5 ULN; Thyroid function index (including TSH, FT3, FT4,TT3, TT4) within normal threshold value; 7. Patients of childbearing potential (male and female) must agree to use reliable contraceptive methods (hormonal or barrier methods or abstinence) with their partners from signing ICF to at least 90 days after the last dosing; For women of reproductive potential, blood pregnancy test must be negative within 7 days before the first dosing; 8. Subjects shall be given informed consent form prior to the study and sign it willingly.
Exclusion criteria
Exclusion criteria: 1. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy and other anti-tumor therapy within 2 weeks prior to the first dose, except for: Nitrourea or mitomycin C used within 6 weeks before the first dose; Small molecule targeted drugs administered within 5 half-lives of the drug. 2. Herbal medicine used within 1 week before study day1. 3. Used other unlisted investigational drug or device within 2 weeks prior to the first dose. 4. Had major organ surgery (excluding puncture biopsy) or significant trauma within 2 weeks prior to the study day1, or needed to undergo elective surgery during the study period; 5. Received systemic glucocorticoids (prednisone > 10mg/ day or equivalent drug) or other immunosuppressive therapy within 2 weeks prior to the first dose,Except for topical, ocular, intraarticular, intranasal, inhaled glucocorticoids, and short-term use of glucocorticoids for prophylactic treatment (e.g. to prevent contrast agent-induced allergic reactions); 6. Used immunomodulator, including but not limited to thymosin, interleukin-2, interferon, etc. within 2 weeks prior to the first dose; 7. Live attenuated vaccine administered within 4 weeks prior to study day1; 8. Prior therapy with TIM3 monoclonal antibody; 9. Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation; 10. Adverse reactions from previous antitumor therapy have not yet resolved to CTCAE v5.0 grade 0 or 1 ( alopecia, pigmentation, neurotoxicity, etc. resolved to grade 2 or below, except for that determined by the researchers to be of no safety risk); 11. Patients of CNS metastases: (1) need local treatment (surgery, radiotherapy or others)(patients of no symptoms or otherwise deemed to need not local treatment); (2) use prednisone > 10mg/ day (or equivalent drug); 12. Patients with active infection requiring treatment; 13. Positive for HBsAg and HBV-DNA>500cps/ml, HCV-RNA, HIV-RNA or TP-Ab; 14. A history of serious cardiovascular and cerebrovascular diseases, including but not limited to: serious heart rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular conductive block, QTc interval >= 450 ms (for male) or >= 470 ms (for female); 15. Patients who used to have autoimmune diseases; 16. Subjects with mental disorders or poor compliance; 17. Women who are pregnant or breastfeeding; 18. Subjects with other serious systemic diseases or reasons deemed by investigator to be unsuitable to enroll in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood routine examination;urine routine test;blood biochemistry;coagulation function;thyroid function;12-Lead electrocardiogram;Adverse events/serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-last, AUC(0-24), AUC (0-8), Cmax, tmax, t1/2, Vd, CL;IL-1 beta, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IFN-gama, TNF-alpha, TBNK, Treg;ADA, Nab;Objective remission rate;Progression free survival;Duration of remission;Disease control rates;echocardiography; | — |
Countries
China
Contacts
Public ContactWu Yilong
Guangdong Provincial People's Hospital
Outcome results
None listed