A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas

Inclusion criteria

• Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies.
• Adequate hepatic function:
• AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases).
• Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome).
• Lipase and amylase ≤ 2×ULN.
• Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using the Cockroft- Gault formula.
• Adequate bone marrow function without growth factors or blood transfusion within 7 days of the first dose of study treatment.
• Absolute neutrophil count (ANC) ≥ 1.5×109/L.
• Platelet count ≥ 100×109/L.
• Hemoglobin ≥ 90 g/L. Key

Exclusion criteria

• Patients with CNS malignancies, except those who are clinically stable for ≥ 4 weeks and off corticosteroids following prior surgery, whole-brain radiation, or stereotactic radiosurgery.
• Received any other investigational product or prior systemic anticancer therapy including chemotherapy, immunotherapy, radiotherapy, or other anticancer within 21 days prior to first dose of study
• Grade ≥3 irAEs or irAEs that lead to discontinuation of prior immunotherapy.8. Other primary malignancies developed within 5 years prior to the first dose of the study treatment
• Other primary malignancies developed within 5 years prior to the first dose of the study treatment
• Have active or previous autoimmune diseases that are likely to recur or are at risk of such diseases judged by the investigator.
• Major cardiovascular disease
• Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by local laboratory, respectively).
• Patients with history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
• A history of allograft organ transplantation for solid tumor or allogeneic hematopoietic stem cell transplantation for B-NHL patients).
• Patients who are pregnant or lactating.