Pancreatic Adenocarcinoma Metastatic Clinical Trial
Official title:
An Open-label, Multicenter, Single-arm, Phase 1b/2 Study of NANT-008 in Combination With 5-fluorouracil, Bevacizumab, Leucovorin, and Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma.
This is a phase 1b/2 study to evaluate the safety and efficacy of NANT-008 in combination with 5-fluorouracil, bevacizumab, leucovorin, and oxaliplatin in patients with metastatic pancreatic adenocarcinoma.
Phase 1b is designed to evaluate the recommended phase 2 dose (RP2D) of NANT-008 and dose-limiting toxicities (DLTs) of NANT-008 in combination with metronomic 5-FU, bevacizumab, leucovorin, and oxaliplatin in subjects with advanced metastatic pancreatic carcinoma. In phase 2, subjects will receive the combination of RP2D of NANT-008 from phase 1b in combination with metronomic 5-FU, bevacizumab, leucovorin, and oxaliplatin. Phase 2 is designed to evaluate the efficacy of the tested regimen as assessed by 1-year survival rate in subjects with advanced metastatic pancreatic adenocarcinoma. ;
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