A Single-center, Open-label, Non-randomized Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SNA028 in Patients With Advanced Colorectal Cancer Positive for GPA33

SmartNuclide Biopharma1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2026年5月1日最近更新: 2026年5月15日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方
入组人数: 20
试验地点: 1
主要终点: To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.

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

This clinical trial is a single-center, open-label, non-randomized first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of SNA028 (which is a two-step radioactivity pretargeting agents conducted by GPA33-CC and 177Lu-SmartD2) in patients with GPA33-positive colorectal cancer who have experienced disease progression/recurrence following prior standard therapy.

详细描述

The trial is planned to explore three main topics: 1.the dose of GPA33-CC. 2. the intervation between administration of GPA33-CC Inervation and 177Lu-SmartD2. 3.the mass dose of SmartD2.

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 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age range of 18 to 75 years old (including boundary values);
•Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
•Individuals with ECOG scores ranging from 0 to 1 (see Appendix 1 for details);
•Life expectancy>6 months;
•Patients with colorectal cancer diagnosed by histopathology or cytology and experiencing imaging progression/recurrence after standard treatment;
•According to RECIST 1.1 definition, there must be at least one measurable lesion;
•Toxicity caused by previous treatment must be restored to ≤ level 2 (CTCAE v6.0) or to a stable state evaluated by the researcher (excluding hair loss and pigmentation);
•Having sufficient organ function, defined as follows:
•1) Bone marrow:
•White blood cell count 3.0~10.0 × 10^9/L
•Absolute neutrophil count 1.5~7.0 × 10^9/L
•Platelets 75~300 × 10^9/L
•Hemoglobin ≥ 90g/L 2) Liver:
•Total bilirubin ≤ 2.5 x upper limit of normal (ULN)
•Serum albumin>3.0 g/dL
•Alanine aminotransferase and aspartate aminotransferase ≤ 3 × ULN or liver metastasis patients ≤ 5 × ULN 3) Kidney:
•Serum/plasma creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft Gault formula) 4) Coagulation function
•The international standardized ratio of prothrombin is less than 1.5 × ULN
•Prothrombin time<2 × ULN
•Patients and/or partners with fertility must use adequate contraceptive measures during the study period and within 6 months after the last administration of the study drug.

排除标准

•Poor nutritional status and inability to tolerate the test subjects;
•Individuals who have previously been allergic to SNA028 components or their analogues;
•Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before SNA028 treatment;
•Patients who have received other experimental anti-tumor drug treatments 4 weeks before SNA028 treatment;
•Patients who received anti-GPA33 antibody treatment 4 weeks before SNA028 treatment;
•Individuals known to have central nervous system metastases and/or malignant meningitis;
•Major comorbidities: including but not limited to New York Heart Association grade III or IV congestive heart failure, a history of congenital QT interval prolongation syndrome, active severe infections, or other major diseases that the researcher deems unsuitable for participation in the study;
•Diagnosed with other malignant tumors that may alter life expectancy or interfere with disease assessment;
•Pregnant or lactating women;
•The researcher believes that they are not suitable to participate in this clinical study.