A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors

Prior treatment

• Concurrent participation in another clinical study.
• Received radiotherapy within 2 weeks prior to the first dose.
• Underwent major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose or plan to undergo major surgery during the study. Underwent interventional or ablation surgery aimed at treating the tumor within 2 weeks before the first dose.
• Prior allogeneic bone marrow transplant or prior solid organ transplant.
• Received systemic corticosteroids or other immunosuppressive treatments within 2 weeks prior to the first dose.
• Received an anthracycline cumulative dose of doxorubicin exceeding 500 mg/m2 or an equivalent dose of other anthracyclines prior to the first dose.
• History of a serious allergic reaction to the investigational product, an inactive ingredient in the investigational product, or other monoclonal antibody.
• Women who are pregnant or breastfeeding as confirmed by pregnancy testing within 3 days prior to first dose.

Other illness

• History of leptomeningeal carcinomatosis or carcinomatous meningitis.
• Uncontrolled or clinically significant cardiovascular or cerebrovascular disease.

Other

• Brain metastasis or spinal cord compression.

• Aged ≥ 18 years (at time of free and informed consent).
• Participants must have radiographically confirmed progressive disease (PD) during the last treatment prior to the first dose of enrollment.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) Dose Escalation Part: ECOG performance status 0 to 1;Backfill Part: ECOG performance status0 to 2.
• Participants must be have HER 2 positive or HER 2 expressing tumors determined by a certified local or central clinical laboratory or hospital
• Organ function must meet the following criteria:
  • i.Hemoglobin (Hb) ≥ 9.0 g/dL ii.Absolute neutrophil count (ANC) ≥ 1.0 × 109/L iii.Platelet count (PLT) ≥ 80 × 109/L v.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN if no liver lesions (primary or metastatic); ALT and AST ≤ 5 × ULN if liver lesions are present vi.Creatinine clearance ≥ 30 mL/min vii.Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN viii. Serum albumin ≥ 25 g/L (2.5 g/dL).
• Expected survival ≥ 3 months.
• Participants must be capable of and willing to comply with the visit and procedure requirements outlined in the protocol.