[Translation] A Phase I clinical trial to evaluate the safety, tolerability, radiation absorbed dose, and distribution characteristics of [68Ga]Ga-NOTA-SNA002 in patients with solid tumors
主要目的
考察[68Ga]Ga-NOTA-SNA002在实体瘤患者中的安全耐受性特征;
考察[68Ga]Ga-NOTA-SNA002在实体瘤患者体内的生物分布特征;
次要目的
考察[68Ga]Ga-NOTA-SNA002在实体瘤患者中的辐射剂量学;
考察[68Ga]Ga-NOTA-SNA002在实体瘤患者中血液的辐射剂量;
考察[68Ga]Ga-NOTA-SNA002在实体瘤患者的PET影像特征;
考察[68Ga]Ga-NOTA-SNA002的最优给药剂量;
考察[68Ga]Ga-NOTA-SNA002的最优成像时间窗。
探索目的
探索[68Ga]Ga-NOTA-SNA002靶病灶PET影像特征(SUVmax、SUVmean、T/B比值等)与免疫组化结果PD-L1表达量的相关性;
探索[68Ga]Ga-NOTA-SNA002的阳性预测和阴性预测效能。
[Translation] Main purpose
To investigate the safety and tolerability characteristics of [68Ga]Ga-NOTA-SNA002 in patients with solid tumors;
To investigate the biodistribution characteristics of [68Ga]Ga-NOTA-SNA002 in patients with solid tumors;
Secondary purpose
To investigate the radiation dosimetry of [68Ga]Ga-NOTA-SNA002 in patients with solid tumors;
To investigate the radiation dose of [68Ga]Ga-NOTA-SNA002 in the blood of patients with solid tumors;
To investigate the PET imaging characteristics of [68Ga]Ga-NOTA-SNA002 in patients with solid tumors;
To investigate the optimal administration dose of [68Ga]Ga-NOTA-SNA002;
To investigate the optimal imaging time window of [68Ga]Ga-NOTA-SNA002.
Purpose of the study
To explore the correlation between the PET imaging characteristics of the target lesions of [68Ga]Ga-NOTA-SNA002 (SUVmax, SUVmean, T/B ratio, etc.) and the expression of PD-L1 in immunohistochemical results;
To explore the positive and negative predictive efficacy of [68Ga]Ga-NOTA-SNA002.