A Phase Ib/IIa, Multicenter, Open-label Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies
This is a multicenter, open-label, phase Ib/IIa study. The first part of the study will evaluate the safety, tolerability and preliminary efficacy of ILB2109 and Toripalimab in patients with locally advanced or metastatic solid malignancies. The second part of the study will evaluate the efficacy of ILB2109 and Toripalimab in patients with selected advanced solid malignancies.
• Adult patients between the ages of 18 and 80 years.
• Patients with histologically or cytologically confirmed solid tumours that are advanced, metastatic and or progressive, for whom there is no effective standard therapy available.
• Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤2.
• Expected life expectancy ≥3 months.
• Evaluable disease, either measurable on imaging, or with informative tumour marker(s), as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Eisenhauer, et al. 2009).
• Laboratory values at Screening:
• Absolute neutrophil count ≥1.5 x 109/L; Platelets ≥75 x 109/L; Hemoglobin ≥ 90g/L; Total bilirubin \<1.5 times the upper limit of normal; Aspartate aminotransferase (AST) ≤3 times the upper limit of normal, ≤ 5 times the upper limit of normal if subject has hepatic malignancies; Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal, ≤ 5 times the upper limit of normal if subject has hepatic malignancies; Estimated glomerular filtration rate (GFR) of \>50 mL/min (based on the Cockcroft-Gault formula; International Normalized Ratio (INR) and activated Partial Thromboplastin Time (aPTT) ≤1.5 times the upper limit of normal; Left Ventricular Ejection Fraction (LVEF) ≥ 50%; Corrected QT Interval by Fridericia Method: male\<450ms, female\<470ms; and
• Negative human chorionic gonadotropin (hCG) test in women of childbearing potential.
• Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 90 days after final administration of ILB-2109, or the patient must be surgically sterile .
• Ability to give written, informed consent prior to any study-specific Screening procedures.