[Translation] An open-label, non-randomized, multi-cohort, multi-center Phase Ia/Ib clinical study evaluating the efficacy and safety of BBP-398 combined with osimertinib in the treatment of locally advanced or metastatic NSCLC patients with EGFR mutations
Ia 期的目的是评估BBP-398 联合奥希替尼治疗在既往接受第三代EGFR TKIs后出现EGFR 突变的局部晚期或转移性非小细胞肺癌受试者的安全性、耐受性、药代动力学和抗癌活性。
Ib 的目的是研究BBP-398 联合奥希替尼治疗伴有EGFR突变的局部晚期或转移性NSCLC 受试者的疗效和安全性。
[Translation] The purpose of phase Ia is to evaluate the safety, tolerability, and pharmacokinetics of BBP-398 combined with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer who have previously received third-generation EGFR TKIs and developed EGFR mutations. Kinetics and anticancer activity.
The purpose of Ib is to study the efficacy and safety of BBP-398 combined with osimertinib in the treatment of locally advanced or metastatic NSCLC subjects with EGFR mutations.