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Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
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/ Not yet recruitingPhase 1 评价 mp105 在晚期非小细胞肺癌、结直肠癌和食管鳞癌患者中的安全性和耐受性的 Ia 期临床研究
[Translation] A Phase Ia clinical study evaluating the safety and tolerability of mp105 in patients with advanced non-small cell lung cancer, colorectal cancer, and esophageal squamous cell carcinoma
主要目的:
1.评估mp105治疗晚期非小细胞肺癌、结直肠癌和食管鳞癌受试者的安全性和耐受性
2.确定mp105治疗晚期非小细胞肺癌、结直肠癌和食管鳞癌受试者的最大耐受剂量(MTD)、扩展推荐剂量(RDE)和/或II期推荐剂量(RP2D)
次要目的:
1.评估mp105治疗晚期非小细胞肺癌、结直肠癌和食管鳞癌受试者的药代动力学(PK)特征
2.评估mp105治疗晚期非小细胞肺癌、结直肠癌和食管鳞癌受试者的抗肿瘤活性
探索性目的:
1.探索mp105治疗晚期非小细胞肺癌、结直肠癌和食管鳞癌受试者的生物标志物特征
2.初步评估mp105的免疫原性
[Translation] Primary Objectives:
1. Evaluate the safety and tolerability of mp105 in patients with advanced non-small cell lung cancer, colorectal cancer, and esophageal squamous cell carcinoma
2. Determine the maximum tolerated dose (MTD), recommended dose for expansion (RDE), and/or recommended phase II dose (RP2D) of mp105 in patients with advanced non-small cell lung cancer, colorectal cancer, and esophageal squamous cell carcinoma
Secondary Objectives:
1. Evaluate the pharmacokinetic (PK) characteristics of mp105 in patients with advanced non-small cell lung cancer, colorectal cancer, and esophageal squamous cell carcinoma
2. Evaluate the anti-tumor activity of mp105 in patients with advanced non-small cell lung cancer, colorectal cancer, and esophageal squamous cell carcinoma
Exploratory Objectives:
1. Explore the biomarker profile of mp105 in patients with advanced non-small cell lung cancer, colorectal cancer, and esophageal squamous cell carcinoma
2. Preliminary assessment of the immunogenicity of mp105
100 Clinical Results associated with Shenzhen Yingsheng Biomedical Co., Ltd.
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100 Translational Medicine associated with Shenzhen Yingsheng Biomedical Co., Ltd.