A Phase 1 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZGGS15 in Patients With Advanced Solid Tumors

ZGGS15-001

This is a multi-center, open-label, Phase 1 clinical study of ZGGS15 for the treatment of patients with advanced solid tumors.

2023-07-19

2024-08-01

2024-08-01

Recruiting

Early phase I

36

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

2023-08-14