A Phase 1, Multi-Center, Open-Label Study Evaluating IBI3028 Treatment in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors
This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors
• Be able to understand and sign written informed consent to participate in this study, including all assessments and procedures specified in this protocol;
• Male or female participants aged 18 years or older;
• Have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors;
• Have at least one evaluable lesion (dose escalation) or measurable lesion (dose expansion) as per RECIST v1.1 within 28 days prior to the first dose of IBI3028;
• ECOG PS（Eastern Cooperative Oncology Group Performance Status）score of 0-1;
• Anticipated life expectancy of ≥ 12 weeks;
• Adequate bone marrow and organ function as evidenced by :
‣ Hematological function: ANC(Absolute neutrophil count) ≥ 1.5 × 10 9 /L; platelet count (PLT) ≥ 90 × 10 9 /L; hemoglobin ≥ 9.0 g/dL, and without receiving granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony stimulating factor (GM-CSF), thrombopoietin (TPO), interleukin-11, or other leukocyte/platelet stimulating growth factors (including red blood cell and platelet transfusions) within at least 7 days before the first dose of the study drug;
⁃ Hepatic function: total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal) (≤ 3 × ULN for participants with Gilbert's syndrome); AST(Aspartate Aminotransferase) and ALT (Alanine Aminotransferase)≤ 2.5 × ULN in the absence of liver metastases (≤ 5 × ULN if liver metastases are present); albumin ≥ 2.8 g/dL;
⁃ Renal function: creatinine clearance ≥ 30 mL/min (using Cockcroft-Gault formula); urine protein \< 2+ or 24-h total urine protein \< 1 g;
⁃ Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, no clinically significant pericardial effusion as determined by ECHO or MUGA(Multigated Acquisition), and no clinically significant ECG result;
⁃ Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (participants receiving anticoagulant therapy with coagulation function within the range above are allowed);
⁃ Pulmonary function: With at least the lowest level of pulmonary reserve, defined as Grade ≤ 1 dyspnea and blood oxygen saturation ≥ 95% in non-oxygen breathing state;
• Participants (both male and female participants) who will be not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study (from start of screening or within 2 weeks prior to first dose, whichever occurs first, and continue until 7 months for females and 4 months for males after the last dose of study drug).