发达固体瘤患者的图萨米他姆拉夫坦辛:使用替代剂量方案对安全性,药理动力学和抗瘤活性进行I期研究

相关实验视频

Updated: Jun 29, 2026

Tumor Treating Field Therapy in Combination with Bevacizumab for the Treatment of Recurrent Glioblastoma

Tumor Treating Field Therapy in Combination with Bevacizumab for the Treatment of Recurrent Glioblastoma

Published on: October 27, 2014

Josep Tabernero¹, Philippe L Bedard², Yung-Jue Bang³

¹Vall d'Hebron Hospital Campus and Institute of Oncology (VHIO), UVic-UCC, IOB-Quirón, Barcelona, Spain.

Cancer research communications

|August 30, 2023

概括

在表达CEACAM5.5的固体瘤患者中,图萨米他马布 (tusamitamab ravtansine) 显示出有利的安全性. 替代剂量表建立了新的最大耐受剂量,为未来的临床试验提供了信息.

科学领域:

在瘤学瘤学.
药理学药理学是一个学科.

背景情况:

图萨米他马布 (Tusamitamab ravtansine) 是一种针对CEACAM5的抗体-药物结合体,具有细胞毒性有效载荷.
之前的一项I期研究确定了每两周一次 (Q2W) 的100mg/m2的最大耐受剂量 (MTD).

研究的目的:

评估在患有晚期固体瘤的患者中使用tusamitamab和ravtansine的替代剂量计划.
确定剂量限制性毒性 (DLT) 和新表的安全性概况.

主要方法:

成年患者 (N=43) 患有CEACAM5表达的固体瘤在不同的时间表中接受了tusamitamab ravtansine:加载剂量 (LD),然后是100 mg/m2 Q2W (n=28) 或固定剂量Q3W (n=15).
主要终点是早期周期的DLT.

主要成果:

在两个方案中,在较高剂量下观察到可逆的DLT.
与治疗相关的不良事件 (AE) 在67.9% (Q2W-LD) 和86.7% (Q3W) 的患者中发生;3名患者因AE而停止治疗.
最常见的副作用包括喘息,胃肠道疾病,角膜病变,角膜炎和外围神经病变. 在35.7% (Q2W-LD) 和40.0% (Q3W) 的患者中观察到稳定的疾病.

结论:

图萨米他马布 (Tusamitamab ravtansine) 在两种测试的替代方案中都显示出有利的安全性.
MTDs被确定为170 mg/m2 (LD),其次是100 mg/m2 Q2W,以及170 mg/m2 Q3W (固定的剂量).
这些发现将指导进一步对CEACAM5表达型固体瘤 (包括非小细胞肺癌) 的tusamitamab ravtansine的研究.

更多相关视频

Pretargeted Radioimmunotherapy Based on the Inverse Electron Demand Diels-Alder Reaction

Pretargeted Radioimmunotherapy Based on the Inverse Electron Demand Diels-Alder Reaction

Published on: January 29, 2019

A Semi-Quantitative Drug Affinity Responsive Target Stability DARTS assay for studying Rapamycin/mTOR interaction

A Semi-Quantitative Drug Affinity Responsive Target Stability DARTS assay for studying Rapamycin/mTOR interaction

Published on: August 27, 2019

相关概念视频

Treatment Resistent Cancers

Treatment Resistent Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...

Pharmacogenetics of Phase II Enzymes: N-acetyltransferase, Thiopurine S-methyltransferase, UDP-glucuronosyltransferase

Pharmacogenetics of Phase II Enzymes: N-acetyltransferase, Thiopurine S-methyltransferase, UDP-glucuronosyltransferase

Phase II biotransformation reactions are essential for detoxifying and eliminating xenobiotics, including many pharmaceutical compounds. These reactions typically involve conjugation, the covalent attachment of polar endogenous groups such as glucuronic acid, sulfate, methyl, or acetyl moieties to functional groups introduced during Phase I metabolism. The resulting conjugates are more water-soluble, enabling efficient renal or biliary excretion.The major classes of Phase II enzymes include...