Adlai Nortye USA Inc

Primary objective: To evaluate the safety and tolerability of Pelareorep combined with paclitaxel injection in Chinese patients with advanced or metastatic breast cancer, and to provide a basis for the formulation of dosing regimens in later clinical trials. Secondary objectives: 1) To evaluate the viral load, viral shedding, viral replication, and neutralizing antibody production of Pelareorep in Chinese patients with advanced or metastatic breast cancer. 2) To preliminarily evaluate the efficacy of Pelareorep combined with paclitaxel injection in the treatment of Chinese patients with advanced or metastatic breast cancer. Exploratory objectives: Biomarker determination in peripheral blood, including gene expression analysis, immune cell clonality determination, genomic mutation detection, and their relationship with efficacy.

BURAN is a randomized, open-label Phase III study designed to evaluate once-daily buparlisib plus weekly paclitaxel versus weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed after prior anti-PD-1/anti-PD-L1 monotherapy or, anti-PD-1/anti-PD-L1 plus platinum therapy or, sequential anti-PD-1/anti-PD-L1 therapy before or after platinum therapy. The primary objectives of this study are as follows: To evaluate the overall survival (OS) of buparlisib plus paclitaxel versus paclitaxel alone in patients with refractory, recurrent, or metastatic HNSCC. The secondary objectives of this study are as follows: To assess other efficacy parameters by investigator and independent radiology review committee (IRRC): progression-free survival (PFS), overall response rate (ORR), and duration of response (DoR). To assess efficacy parameters in patient subgroups defined by randomization stratification. To evaluate the effect of Buparlisib combined with paclitaxel on symptoms and health-related quality of life (HRQoL). To evaluate the pharmacokinetics (PK) of Buparlisib combined with paclitaxel.