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A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
Trial Status: active
ATG-031 study (alias: PERFORM) is a multicenter, open-label, Phase 1 study of ATG-031 in
patients with advanced solid tumors or B-NHL. The study design includes a Dose Escalation
Phase and a Dose Expansion Phase, and will enroll patients with advanced solid tumors
(i.e., preferred tumor types) or relapsed/refractory (R/R) B-NHLs. The study's primary
objective is to evaluate the safety and tolerability of ATG-031 and determine the
RP2D（Refered Phase II dose） of ATG-031.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06028373.
