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

NCT06904378 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ONT01

Per assigned dose level.

DRUG

Gemcitabine

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

DRUG

Nab paclitaxel

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Patrick Grierson, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2028-09-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06904378 on ClinicalTrials.gov