抗肿瘤抗体偶联药物非临床药理毒理研究的考虑要点

Considerations on nonclinical pharmacology and toxicology studies of antibody-drug conjugates for oncology

抗肿瘤抗体偶联药物通过靶向释放药物,可降低细胞毒药物的毒性风险,提高治疗指数。抗体偶联药物的组成复杂,与裸单抗和细胞毒药物相比,抗体偶联药物的研发具有更大的挑战。本文基于ICH S6和ICH S9等指导原则,探讨了抗肿瘤抗体偶联药物的非临床药理、安全性以及药动学研究的关注点和考虑。

Antibody-drug conjugates （ADCs） as anti-cancer agents are designed to improve the therapeutic index of the cytotoxin by specifically delivering cytotoxin to tumor cells. The development path for ADCs is more complex and challenging than for unmodified antibodies or cytotoxin. This paper presents primary considerations on the nonclinical pharmacology, toxicology and pharmacokinetic studies of ADCs, mainly based on ICH S6 and ICH S9 guidelines.