Phase I dose escalation for triple combination therapy with BOINcomb design,The safety (including DLT), tolerability, and PK are the study endpoints of phase I and to determine MTD and RP2D. Phase II is a multi-center, randomized, open-label, four parallel arms designed study to assess the anti-cancer efficacy, safety and biomarker correlation to efficacy. The therapies in the four treatment arms are: LAE005 + afuresertib + nab-paclitaxel; LAE005 + nab-paclitaxel; afuresertib + nab-paclitaxel; and nab-paclitaxel monotherapy, respectively. The ORRs based on RECIST 1.1 of four therapies are the primary endpoint, whereas the DOR, PFS, DCR are the secondary endpoints in phase II study.
PhI Dose Escalation with BOIN design in advanced Solid Tumor with Triple combination therapy to determine MTD and RP2D and Phase II is open label randomized four parallel arms to access anti tumour efficacy in mTNBC