BY-101921

BY101921 is a novel small molecule, being developed as a PARP7 inhibitor which acts on the PARP7 catalytic subunit, for the treatment of solid tumors. PARP7 is a member of the monoPARP family and involved in various biological processes such as gene expression, protein degradation, and cellular stress response. The results of non-clinical studies showed BY101921 was a potent inhibitor of PARP7 and had good selectivity.
The primary objective is to assess the safety and tolerability and MTD of BY101921 in patients with refractory or metastatic solid tumors. This study will also evaluate pharmacokinetic (PK) profile, preliminary anti-tumor activity, major metabolites and biomarkers in patients with refractory or metastatic solid tumors.

主要目的： 1）评价BY101921在晚期实体瘤患者中的安全性、耐受性 2）确定BY101921的最大耐受剂量（MTD） 次要目的： 1）评价BY101921在晚期实体瘤患者中的药代动力学（PK）特征 2）初步评估BY101921在晚期实体瘤患者中的有效性 探索性目的： 1）评估BY101921在晚期恶性实体瘤患者血浆中的代谢物谱 2）评估BY101921在晚期恶性实体瘤患者中的预测性生物标志物与有效性的关系