A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas

Antengene Biologics Limited7 个研究点分布在 1 个国家目标入组 38 人开始时间: 2023年12月8日最近更新: 2026年7月16日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: Antengene Biologics Limited
入组人数: 38
试验地点: 7
主要终点: RP2D

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

This 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. Dose Escalation Phase: approximately 30-48 patients . Dose Expansion Phase: the number of patients enrolled will depend on the number of disease cohorts to be expanded and data observed in the Dose Escalation Phase.The Dose Escalation Phase will enroll patients with advanced solid tumors. Based on data from dose escalation (e.g., adverse events [AEs], dose-limiting toxicity [DLT], efficacy data, pharmacodynamic [PDx] data, or pharmacokinetic [PK] data), the Dose Expansion Phase will enroll patients with selected advanced solid tumors or B-NHL.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.
•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.