A Phase II, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of HB0025 in Patients With Advanced Renal Cancer
It is a phase II open label, multicenter study to assess the safety, tolerability, pharmacokinetics, and efficacy of HB0025 in patients with advanced clear cell renal cell carcinoma (ccRCC).
• Male or female. Age ≥ 18 years.
• The subject is able to understand and willing to sign the informed consent form (ICF) ; willing and able to comply with all study procedures.
• Patients with histologically and/or cytologically confirmed advanced clear cell renal cell carcinoma (defined as more than 50% clear cell component) that is not suitable for radical treatment or recurrence / metastasis, with or without sarcomatoid features; may benefit from investigational drug therapy as judged by the investigator; and who have disease progression after receiving at least one previous systemic treatment regimen (tyrosine kinase drugs such as sunitinib, axitinib, pazopanib, sorafenib, etc., other drugs such as everolimus, excluding treatment with immune checkpoint inhibitors) or who cannot tolerate the current standard treatment as judged by the investigator.
• At least one measurable tumor lesion was present according to RECIST 1.1. At the same scan level of CT or MRI scan, the longest diameter of non-lymph node lesions is at least 10 mm, and the short diameter of lymph node lesions is ≥ 15 mm. A baseline imaging assessment could be performed up to 28 days before the first dose.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
• Life expectancy ≥3 mouths
• liver function requirements:
‣ Total bilirubin (TBIL) ≤ 1.5×ULN
⁃ Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5×ULN; AST or ALT ≤5×ULN if liver metastases are present.
• Creatinine (Scr) \< 1.5×ULN and Calculated creatinine clearance (CrCL) \> 40 mL/ min (Cockcroft-Gault Equation).
• Hematology：
‣ absolute neutrophil count (ANC) ≥ 1,500/µL. (No use of recombinant human granulocyte colony-stimulating factor to support treatment within 14 days before the first administration of HB0025).
⁃ hemoglobin (HGB) ≥ 9 g/dL. (No transfusion or hemoglobin support within 14 days of HB0025 first administration).
⁃ platelets (PLT) ≥ 75,000/µL. (No transfusion or recombinant human thrombopoietin support within 14 days of HB0025 first administration).