|
MechanismEpCAM inhibitors |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Not yet recruitingPhase 1 一项评价IMC001在上皮性晚期实体瘤受试者中的安全性及疗效的I/IIa期临床试验
[Translation] A phase I/IIa clinical trial evaluating the safety and efficacy of IMC001 in patients with advanced epithelial solid tumors.
I期:
主要目的
评估IMC001的安全性和耐受性以确定推荐进入IIa期的剂量(RP2D)
次要目的
评价IMC001的初步抗肿瘤活性
评价IMC001的药代动力学(PK)和药效学(PD)特性 IIa期
主要目的
评估IMC001在接受标准治疗失败的实体瘤受试者中的疗效
次要目的
评估IMC001的安全性和其他疗效终点
评价IMC001的药代动力学(PK)和药效学(PD)特性 探索性目的(适用于 I 期及 IIa 期研究)
进行免疫原性分析、慢病毒基因组插入位点、复制型慢病毒(RCL)等长期随访。
评估IMC001给药前后的细胞因子变化以及与疗效和安全性的相关性。
评估IMC001 给药前后的生物标志物变化与疗效和安全性的相关性。
评估IMC001给药前后的CAR-T细胞表型变化。
评估IMC001 给药前后肿瘤组织样本的肿瘤微环境的变化与疗效和安全性的相关性。
探索上述以及其他相关生物标志物与疗效及安全性的相关性
[Translation] Phase I:
Primary Objective
To assess the safety and tolerability of IMC001 to determine the recommended dose for Phase IIa (RP2D)
Secondary Objectives
To evaluate the preliminary antitumor activity of IMC001
To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of IMC001
Phase IIa:
Primary Objective
To assess the efficacy of IMC001 in subjects with solid tumors who have failed standard therapy
Secondary Objectives
To assess the safety and other efficacy endpoints of IMC001
To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of IMC001
Exploratory Objectives (Applicable to Phase I and IIa studies):
To perform immunogenicity analysis, lentiviral genomic insertion site assays, and long-term follow-up including replicating lentivirus (RCL) assays.
To assess cytokine changes before and after IMC001 administration and their correlation with efficacy and safety.
To assess the correlation between changes in biomarkers before and after IMC001 administration and their correlation with efficacy and safety.
To assess CAR-T cell phenotypic changes before and after IMC001 administration.
To assess the correlation between changes in the tumor microenvironment in tumor tissue samples before and after IMC001 administration and their relationship to efficacy and safety.
To explore the correlation between the above-mentioned and other relevant biomarkers and efficacy and safety.
100 Clinical Results associated with Chengdu Yimoufeng Biotechnology Co., Ltd.
0 Patents (Medical) associated with Chengdu Yimoufeng Biotechnology Co., Ltd.
100 Deals associated with Chengdu Yimoufeng Biotechnology Co., Ltd.
100 Translational Medicine associated with Chengdu Yimoufeng Biotechnology Co., Ltd.