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MAX-40279联合VA方案治疗不适合强化疗的新诊断急性髓系白血病患者的临床研究
[Translation] Clinical study of MAX-40279 combined with VA regimen in the treatment of newly diagnosed acute myeloid leukemia patients who are not suitable for intensive chemotherapy
主要目的:
1) 第1阶段:评估MAX-40279联合维奈克拉片+阿扎胞苷方案(简写“VA”)治疗不适合强化疗的新诊断急性髓系白血病(AML)患者的安全性和耐受性,确定推荐剂量(RP2D)。
2) 第2阶段:评估MAX-40279联合VA治疗不适合强化疗的新诊断AML的复合完全缓解率(CRc)。
次要目的:
1) 评估MAX-40279联合VA治疗不适合强化疗新诊断AML的其他疗效指标。
2) 评估MAX-40279联合VA治疗的药代动力学(PK)特征。
探索性目的:
1) 探索性分析与疗效相关的潜在生物标志物。
[Translation] Primary objectives:
1) Phase 1: To evaluate the safety and tolerability of MAX-40279 combined with venetoclax tablets + azacitidine regimen (abbreviated as "VA") in the treatment of newly diagnosed acute myeloid leukemia (AML) patients who are not suitable for intensive chemotherapy, and determine the recommended dose (RP2D).
2) Phase 2: To evaluate the composite complete remission rate (CRc) of MAX-40279 combined with VA in the treatment of newly diagnosed AML who are not suitable for intensive chemotherapy.
Secondary objectives:
1) To evaluate other efficacy indicators of MAX-40279 combined with VA in the treatment of newly diagnosed AML who are not suitable for intensive chemotherapy.
2) To evaluate the pharmacokinetic (PK) characteristics of MAX-40279 combined with VA.
Exploratory objectives:
1) To explore and analyze potential biomarkers associated with efficacy.
MAX-10181联合TMZ治疗高级别脑胶质瘤患者的安全性和有效性的Ⅱ期临床研究
[Translation] Phase II clinical study on the safety and efficacy of MAX-10181 combined with TMZ in the treatment of patients with high-grade brain glioma
1)评估MAX-10181联合替莫唑胺(TMZ)在复发/进展高级别脑胶质瘤(HGG)患者中的安全性和耐受性、药代动力学、联合用药推荐剂量(RP2D)。 2)评估MAX-10181联合TMZ治疗初治脑胶质瘤患者的初步疗效。
[Translation] 1) To evaluate the safety and tolerability, pharmacokinetics, and recommended combined dose (RP2D) of MAX-10181 combined with temozolomide (TMZ) in patients with recurrent/progressive high-grade glioma (HGG). 2) To evaluate the preliminary efficacy of MAX-10181 combined with TMZ in patients with newly diagnosed glioma.
MAX-10181联合卡培他滨片治疗晚期/转移性实体瘤患者的安全性和有效性的临床研究
[Translation] Clinical study on the safety and efficacy of MAX-10181 combined with capecitabine tablets in the treatment of patients with advanced/metastatic solid tumors
主要目的:1)第一阶段:评估MAX-10181联合卡培他滨在晚期/转移性实体瘤患者中的耐受性及安全性,确定MAX-10181联合卡培他滨在不同实体瘤中的推荐剂量(RP2D)。2)第二阶段:评估MAX-10181联合卡培他滨在晚期/转移性实体瘤患者中的初步疗效。次要目的:1)评价MAX-10181联合卡培他滨治疗晚期/转移性实体瘤患者的药代动力学(PK)特征。2)回顾性分析相关生物标志物与MAX-10181联合卡培他滨抗肿瘤效应之间的关系。
[Translation] Primary objectives: 1) Phase I: Evaluate the tolerability and safety of MAX-10181 combined with capecitabine in patients with advanced/metastatic solid tumors, and determine the recommended dose (RP2D) of MAX-10181 combined with capecitabine in different solid tumors. 2) Phase II: Evaluate the preliminary efficacy of MAX-10181 combined with capecitabine in patients with advanced/metastatic solid tumors. Secondary objectives: 1) Evaluate the pharmacokinetic (PK) characteristics of MAX-10181 combined with capecitabine in the treatment of patients with advanced/metastatic solid tumors. 2) Retrospectively analyze the relationship between relevant biomarkers and the anti-tumor effect of MAX-10181 combined with capecitabine.
100 Clinical Results associated with Guangzhou Zaiji Medical Technology Co., Ltd.
0 Patents (Medical) associated with Guangzhou Zaiji Medical Technology Co., Ltd.
100 Deals associated with Guangzhou Zaiji Medical Technology Co., Ltd.
100 Translational Medicine associated with Guangzhou Zaiji Medical Technology Co., Ltd.