[Translation] A Phase 1a/1b study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of the CDK4 inhibitor BGB-43395 alone or in combination with other agents in Chinese patients with advanced or metastatic HR+/HER2- breast cancer and other solid tumors
剂量递增阶段:
评估 BGB-43395单药治疗用于晚期实体瘤中国患者,或与其他药物联合用于 HR+/HER2-乳腺癌中国患者时的安全性和耐受性、最大耐受剂量(MTD)或最大给药剂量(MAD)以及扩展期推荐剂量(RDFE)、初步抗肿瘤活性、PK 特征及其代谢物BGB-48579的PK特征。
剂量扩展阶段:
在选定肿瘤队列中评估 BGB-43395 单药治疗或与其他药物联合在中国患者中的抗肿瘤活性、安全性和耐受性、评估 BGB-43395及其代谢物 BGB-48579在联合治疗中的PK特征。
[Translation] Dose escalation phase:
Evaluate the safety and tolerability of BGB-43395 as a monotherapy in Chinese patients with advanced solid tumors or in combination with other drugs in Chinese patients with HR+/HER2- breast cancer, the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended dose for extension (RDFE), preliminary antitumor activity, PK characteristics and PK characteristics of its metabolite BGB-48579.
Dose expansion phase:
Evaluate the antitumor activity, safety and tolerability of BGB-43395 as a monotherapy or in combination with other drugs in Chinese patients with selected tumor cohorts, and evaluate the PK characteristics of BGB-43395 and its metabolite BGB-48579 in combination therapy.