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ONT01 + Gemcitabine and Nab-Paclitaxel

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

  • RegistryNCT06904378
  • PhasePhase 1/2
  • StatusRecruiting
  • ConditionMetastatic Pancreatic Ductal Adenocarcinoma (Second Line)
  • SponsorWashington University School of Medicine
How ONT01 + Gem/Nab-Paclitaxel works1 min

The drug

What is being tested.

The dose of nab-paclitaxel is 125 mg/m^2.

The dose of gemcitabine is 1000 mg/m^2.

The study

How the trial runs.

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.

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas.
  • Measurable or evaluable disease per RECIST 1.1.
  • Previously treated with first-line systemic therapy for unresectable/advanced or metastatic PDAC and experienced progression or became intolerant to the therapy and is in need of another line of systemic therapy in the opinion of the investigator.
  • At least 18 years of age.
  • ECOG performance status ≤ 1.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

For you, or someone you love

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