一项AL8326 片联合特瑞普利单抗治疗晚期复发或转移性实体瘤I/IIa期临床试验
[Translation] A Phase I/IIa clinical trial of AL8326 tablets combined with toripalimab in the treatment of advanced recurrent or metastatic solid tumors
主要目的:评估 AL8326 片联合特瑞普利单抗(Toripalimab)治疗晚期实体瘤的安全性及耐受性,观 察 DLT 的发生,确定 MTD 及 RP2D。
次要目的:初步获得 AL8326 片联合特瑞普利单抗(Toripalimab)治疗晚期实体瘤受试者的药代动力 学参数(仅第一部分)。 初步评价 AL8326 片联合特瑞普利单抗(Toripalimab)治疗晚期实体瘤的有效性
[Translation] Primary objective: To evaluate the safety and tolerability of AL8326 tablets combined with Toripalimab in the treatment of advanced solid tumors, observe the occurrence of DLT, and determine the MTD and RP2D.
Secondary objective: To preliminarily obtain the pharmacokinetic parameters of AL8326 tablets combined with Toripalimab in the treatment of advanced solid tumors (only the first part). Preliminary evaluation of the effectiveness of AL8326 tablets combined with Toripalimab in the treatment of advanced solid tumors
/ Active, not recruitingPhase 1 AL8326 治疗小细胞肺癌为主的晚期肿瘤患者的剂量递增耐受性 的 I 期临床研究
[Translation] Phase I clinical study of AL8326 in patients with advanced tumors, mainly small cell lung cancer, to evaluate the tolerability of dose escalation
主要目的:观察晚期小细胞肺癌(允许包括少量膀胱癌、乳腺癌、胃肠间质瘤、胆管癌或其他实体瘤)患者多次给予AL8326后的耐受性和安全性,药物在人体的DLT和MTD, 毒性的可逆程度、毒性与剂量关系。
次要目的:为II期临床推荐合适的给药剂量和方案;初步分析在晚期小细胞肺癌(允许包括少量膀胱癌、乳腺癌、胃肠间质瘤、胆管癌或其他实体瘤)患者中的疗效。
[Translation] Primary purpose: To observe the tolerance and safety of AL8326 after multiple administration in patients with advanced small cell lung cancer (including a small amount of bladder cancer, breast cancer, gastrointestinal stromal tumor, bile duct cancer or other solid tumors), the DLT and MTD of the drug in humans, the reversibility of toxicity, and the relationship between toxicity and dose.
Secondary purpose: To recommend appropriate dosage and regimen for Phase II clinical trials; to preliminarily analyze the efficacy in patients with advanced small cell lung cancer (including a small amount of bladder cancer, breast cancer, gastrointestinal stromal tumor, bile duct cancer or other solid tumors).
/ Not yet recruitingPhase 1 AL58805 片在血液肿瘤受试者中的耐受性和药代动力学I期临床研究
[Translation] Phase I clinical study on the tolerability and pharmacokinetics of AL58805 tablets in subjects with hematological malignancies
主要目的:1、研究血液肿瘤患者单次和多次给予 AL58805 后的耐受性和安全性,观测给药后人体的剂量限制性毒性(DLT)和最大耐受剂量(MTD),毒性的可逆程 度、毒性与剂量关系。2、初步研究分析 AL58805 片在血液肿瘤患者体内的药代动力学特征;
次要目的:1、根据 I 期耐受性试验和药代动力学结果为 II 期临床试验推荐合适的给药剂量 和方案;2、初步评估 AL58805 在血液肿瘤患者中的疗效
[Translation] Main purpose: 1. To study the tolerance and safety of AL58805 after single and multiple administrations in patients with hematological tumors, to observe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) in humans after administration, the reversibility of toxicity, and the relationship between toxicity and dose. 2. To preliminarily study and analyze the pharmacokinetic characteristics of AL58805 tablets in patients with hematological tumors;
Secondary purpose: 1. To recommend appropriate dosage and regimen for Phase II clinical trials based on Phase I tolerance test and pharmacokinetic results; 2. To preliminarily evaluate the efficacy of AL58805 in patients with hematological tumors
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