RecruitingPhase 1Phase 2NCT06904378

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

Phase I/II Clinical Trial of ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma: Reprogramming Tumor-associated Myeloid Cells


Sponsor

Washington University School of Medicine

Enrollment

61 participants

Start Date

Mar 25, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Gemcitabine, a drug called Nab paclitaxel, and others for people with metastatic pancreatic ductal adenocarcinoma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGONT01

Per assigned dose level.

DRUGGemcitabine

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

DRUGNab paclitaxel

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


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06904378


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