New drug ATG-031 targets Hard-to-Treat cancers in first human trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies. 2. Adequate hepatic function: 1. AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases). 2. Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome). 3. Lipase and amylase ≤ 2×ULN. 3. Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using the Cockroft- Gault formula. 4. Adequate bone marrow function without growth factors or blood transfusion within 7 days of the first dose of study treatment. 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L. 2. Platelet count ≥ 100×109/L. 3. Hemoglobin ≥ 90 g/L. Key Exclusion Criteria: 1. 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. 2. 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 3. 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 4. Other primary malignancies developed within 5 years prior to the first dose of the study treatment 5. Have active or previous autoimmune diseases that are likely to recur or are at risk of such diseases judged by the investigator. 6. Major cardiovascular disease 7. Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by local laboratory, respectively). 8. Patients with history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 9. A history of allograft organ transplantation for solid tumor or allogeneic hematopoietic stem cell transplantation for B-NHL patients). 10. Patients who are pregnant or lactating.