BAT7104 in Patients With Advanced Solid Tumours

Inclusion Criteria

• •1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
• •2. Aged ≥ 18 years
• •3. Life expectancy ≥ 3 months.
• •4. Eastern Cooperative Oncology Group （ECOG）performance status ≤ 1.
• •5. Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy, or for whom no standard therapy exists, and where standard therapy is contraindicated or has been declined by the patient. Note that certain malignancies can be included based on imaging (e.g., HCC) and can be included based on the discretion of the PI, Sponsor Medical Monitor approval.
• •6. Has measurable or evaluable disease per RECIST v1.1. that was not in a prior radiation or other locally treated area, unless imagingbased progression has been clearly documented following radiation or other local therapy.
• •7. Adequate haematological, liver, and kidney function
• •8. International normalized ratio (INR) /prothrombin time (PT)\< 2, activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limits of normal （ULN）.
• •9. Must agree to adhere to the current state and national advice regarding minimising exposure to COVID-19 from the first Screening visit until the end of study (90-day follow-up) visit.
• •5. Had major surgery within 28-days of the Screening visit. Note: Patients who have undergone a surgical procedure ≥ 28-days prior to Screening must have recovered adequately from the toxicity and/or complications from the intervention before the first dose of study drugs. Exception: no waiting period applies following port-a-cath placement for venous access.
• •6. History of tissue or organ transplantation.
• •7. History of severe infection deemed clinically significant by the PI or designee within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose of study drugs.
• •8. History of human immunodeficiency virus (HIV) infection or history of autoimmune diseases.
• •9. Active hepatitis B or C.
• •10. History of a Grade 3 or Grade 4 allergic reaction to treatment with another monoclonal antibody.