Advanced malignant solid tumor
Conditions
Interventions
3mg fixed dose group:3mg fixed dose
10mg fixed dose group:10mg fixed dose
30mg fixed dose group:30mg fixed dose
100mg fixed dose group:100mg fixed dose
300mg fixed dose group:300mg fixed dose
600mg fixed dose group:600mg fixed dose
900mg fixed dose group:900mg fixed dose
Sponsors
Shanghai Oriental Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, gender: male or female; 2. The expected survival period assessed by the investigator is at least 3 months; 3. The Eastern Cooperative Oncology Group (ECOG) performance status score is required to be 0 or 1; 4. Patients with locally advanced or metastatic malignant solid tumors confirmed by histology or cytology without standard treatment, or for whom standard treatment has failed, or standard treatment is not applicable; 5. According to the tumor efficacy evaluation standard RECIST 1.1, there must be an evaluable tumor lesion in the dose escalation phase, and there must be at least one measurable tumor lesion in the dose expansion phase; 6. Sufficient organ and bone marrow reserve function, defined as follows: blood routine (no blood transfusion within 14 days before the first administration, no use of hematopoietic stimulating factors, and no use of drugs to correct blood cell count): absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelet count >= 75 x 10^9/L; hemoglobin >= 85g/L; coagulation function: prothrombin time (PT) or International normalized ratio (INR) and activated partial thromboplastin time (APTT) 50ml/min; 7. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and be willing to take effective birth control/contraceptive methods to prevent pregnancy during the study period until 6 months after the last dose of the study. Male patients must agree to use effective contraception during the study period until 6 months after the last study dose; postmenopausal women must have been amenorrhea for at least 12 months to be considered infertile.
Exclusion criteria
Exclusion criteria: 1. Previously received anti-TIGIT monoclonal antibody or double antibody with anti-TIGIT activity; 2. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of the study drug, except for the following: nitrosoureas or mitomycin C are the first use of the study drug Within the first 6 weeks; Oral fluorouracil and small molecule targeted drugs are the first 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer); Chinese medicines with anti-tumor indications are the first use of the study drug within the first 2 weeks. 3. Received other unmarketed clinical research drugs or treatments within 4 weeks before the first use of the study drug; 4. Have been vaccinated within 4 weeks before screening or plan to be vaccinated with live/attenuated vaccines and mRNA vaccines during the study period; 5. Pregnant or breastfeeding women; 6. Patients with AEs caused by previous anti-tumor therapy that have not recovered to CTCAE 5.0 = grade 3 allergic reactions to macromolecular protein preparations/monoclonal antibodies; 16. Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), or have had autoimmune diseases that may recur, except clinically stable autoimmune thyroid diseases, I type diabetes patients; 17. Received systemic corticosteroids (prednisone > 10mg/day or equivalent dose of similar drugs) or other immunosuppressive therapy within 14 days before the first use of the study drug; except for the following cases:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose;maximum dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;immunogenicity;Pharmacodynamic properties;Antitumor efficacy; | — |
Countries
China
Contacts
Public ContactLi Jin
Shanghai Oriental Hospital
Outcome results
None listed