Clinical Trial

ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma

Recruiting Phase 1/2
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Summary
The investigators hypothesize that CD11b agonism reprograms the tumor microenvironment (TME) to overcome resistance to checkpoint immunotherapy in pancreatic ductal adenocarcinoma (PDAC). Therefore, the investigators propose an open label phase I/II clinical trial of ONT01 with gemcitabine and nab-paclitaxel in unresectable pancreatic ductal adenocarcinoma prior to future studies incorporating anti-PD1 checkpoint immunotherapy.
Protocol Amendment History 1 change
critical Recruitment opened 2026-03-31
Trial Details
NCT Number NCT06904378
Lead Sponsor Washington University School of Medicine
Collaborators: National Cancer Institute (NCI)
Conditions Metastatic Pancreatic Ductal Adenocarcinoma
Enrollment 61 participants
Start Date 2026-03-25
Primary Completion 2028-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-19