study of zggs15 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a multi-center, open-label, phase 1 clinical study of zggs15 for the treatment of patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * fully understand the study and voluntarily sign the informed consent form; * male or female, 18-70 years of age; * histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom the available standard treatments failed; * must have at least 1 measurable lesion per recist v1.1; * eastern cooperative oncology group performance status of 0 or 1; * life expectancy ≥ 3 months; * all adverse events from prior treatment have either returned to baseline or ctcae v5.0≤grade 1; * both male and female participants (unless postmenopausal, surgical sterilization) and partners must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug. exclusion criteria: * medical history, computed tomography (ct) or magnetic resonance imaging (mri) results indicate the existence of the central nervous system (cns) metastases； * uncontrollable third cavity effusion requiring repeated drainage, which was judged by the investigator to be unsuitable for study; * the main organ function meets any of the following criteria within 7 days prior to treatment: * hematological function: absolute neutrophil count (anc) \< 1.5 × 10\^9/l, platelet (plt) \< 75 × 10\^9/l, or hemoglobin (hb) \< 100 g/l; * hepatic function: alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≥ 3 × upper limit of normal (uln), alt and ast ≥ 5×uln for patients with liver metastases; total bilirubin (tbil) ≥ 1.5×uln; albumin \< 30 g/l; * blood cholesterol \> 300 mg/dl or \> 7.75 mmol/l; * creatinine clearance (cockcroft-gault formula) \< 50 ml/min; * international normalized ratio (inr) \> 1.5 or activated partial thromboplastin time (aptt) \> 1.5×uln; * any other malignancy within 5 years; * abnormal thyroid function with clinical symptoms or diabetes, which cannot be controlled by available treatments; * history of autoimmune disease, including but not limited to systemic lupus erythematosus, nephritis, psoriasis, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis; * previous immune checkpoint inhibitors induced ≥ grade 2 immune-related adverse reactions in vital organs, including but not limited to myocarditis and central nervous system toxicity; rapidly tumor progressed after previous pd-1 inhibitor treatment; * interstitial lung disease, non-infectious pneumonitis, and radiation-induced pneumonia with symptoms and/or requiring steroids for treatment; * received prior allogeneic stem cell transplantation or solid organ transplantation; * active infection within 1 week before the first administration currently requires systemic anti-infective therapy; * known allergy to other mabs or any antibody excipient, severe allergic reaction to humanized antibodies or fusion proteins, and history of anaphylactoid reaction or other hypersensitivity reactions; * known history of diagnosed neurological or mental disorders, for example, epilepsy, dementia, etc.; * patients were deemed unsuitable for participating in the study by the investigator for any reason.