An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Efficacy of Paclitaxel in Combination With Pembrolizumab and Olaparib as a Second Line Treatment in Immune Checkpoint Inhibitor-experienced Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer.
Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD 1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Olaparib is a potent PARP inhibitor (PARP1, 2, and 3) that is being developed as a monotherapy as well as for combination with chemotherapy, ionizing radiation, and other anti-cancer agents including novel agents and immunotherapy. Paclitaxel is widely used in breast, lung and gastric cancer with every 3-week or weekly cycle. Various targeted anticancer agents have been investigated with paclitaxel and combination with ramucirumab, a monoclonal anti-VEGFR2 antibody, was approved as a 2nd line treatment.
• Provided written informed consent for treatment.
• Age ≥ 19 years old
• measurable or evaluable disease based on RECIST 1.1. Lesions
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on time of patient's allocation.
• Adequate organ function as defined by the following criteria:
• A life expectancy of at least 3 months
• Is able to swallow and retain orally administered medications
• Failed first-line trastuzumab treatment for HER2 positive patients
• Highly effective contraception for both male and female subjects if the risk of conception exists.
⁃ Left ventricular ejection fraction (LVEF) ≥50%