A Phase I/IIa Randomized Clinical Trial to Evaluate the Efficacy of EGFR-targeted, PNU-159682-packaged Nanocells & Glycolipid-Packaged Nanocells in Combination With Gemcitabine & Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma
The purpose of this study is to evaluate the safety and tolerability and overall survival (OS) of E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel versus gemcitabine and nab-paclitaxel alone in participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on therapy.
• Histological or pathological confirmation of metastatic pancreas adenocarcinoma. Cytological or histological evidence of metastatic disease is required.
• Male or Female greater than or equal to 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
• Life expectancy ≥ 3 months in the opinion of the Investigator.
• Measurable disease as per iRECIST criteria.
• Subjects must have tumors that express EGFR.
• Documented disease progression with first line FOLFIRINOX or NALIRIFOX therapy, during or within 3 months (+/- 15 days) after end of therapy.
• No more than one line of prior systemic therapy for metastatic PDAC allowed.
• Albumin level \> 3.0 g/dl
• Adequate hematological function.
• Adequate renal function.
• Adequate hepatic function.
• Adequate cardiac function with LVEF ≥ 50% at baseline.
• Reproductive criteria as follows:
• Female subjects who are of non-reproductive potential
• Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose.
• Female subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.
• Male subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.
• All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
• The subject (or subject's legally authorized representative) has provided voluntary signed informed consent.
• According to the investigator's assessment, subject will be able to comply with the study protocol.