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Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Pancreatic Cancer Patients — OPTIMIZE-1  

Metastatic Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:
An Open-label Phase 1b/2 Study Assessing the Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Clinical Trial Summary

Phase 1b/2 study to assess the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.

Clinical Trial Description

OPTIMIZE-1 is a phase 1b/2, open-label, multi-center study assessing the clinical efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma. The efficacy of intravenously administered mitazalimab in combination with the standard of care chemotherapy mFOLFIRINOX will be evaluated in patients with metastatic pancreatic ductal adenocarcinoma. Two dose levels of mitazalimab, 450 ug/kg and 900 ug/kg, are planned to be evaluated together with mFOLFIRINOX for determination of recommended phase 2 dose (RP2D) of mitazalimab in combination with mFOLFIRINOX before entering a dose expansion part with RP2D obtained. The expansion part will evaluate the clinical efficacy of mitazalimab in combination with mFOLFIRINOX assessing objective response rate (ORR), primary endpoint, as well as Progression-free survival (PFS) and Overall survival (OS). The dose expansion part includes a Simon´s two-stage design with an interim analysis for stop for futility or efficacy based on ORR. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04888312
Study type Interventional
Source Alligator Bioscience AB
Contact Philip Van Der Veen
Phone +44(0) 1293 510319
Email PVanDerVeen@Theradex.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 17, 2021
Completion date June 30, 2025
View Details
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