An Open Label, Multiple Centers Phase Ib/II Study of APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
This study is a two stage study consisting of a dose escalation phase Ib and a phase II study which include subjects with previously-treated, advanced pancreatic adenocarcinoma. Dose Limiting Toxicities (DLTs) and maximum tolerated dose (MTD) of APG1387 in combination with nab-paclitaxel and gemcitabine will be evaluated in the dose escalation phase Ib. Safety and efficacy of APG1387 plus gemcitabine and nab-paclitaxel will be evaluated in phase II.
• Subjects must be ≥18 years of age at time of informed consent
• Able to comply with the study protocol, in the investigator's judgment
• Expected survival ≥ 3 months
• Histology or cytology confirmed as advanced pancreatic adenocarcinoma, and:
‣ Standard treatment failed or intolerant to standard treatment(Phase Ib);
⁃ First line standard treatment failed (Phase II).
• ECOG 0-1;
• Adequate organ function.
• Subjects must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment