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NCT06904378 · ClinicalTrials.gov registry record · Phase 1
ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1 study, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT06904378: Recruiting Phase 1 study, sponsored by Washington University School of Medicine.
NCT06904378 is a Phase 1 study that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06904378, a Phase 1 study, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
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.
Primary Outcome
The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. In the absence of excess toxicity, the maximum tolerated dose will become the recommended phase 2 dose (RP2D).
Interventions
- DRUG Gemcitabine
- DRUG Nab paclitaxel
- DRUG ONT01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2026-03-25 |
| Est. Completion | 2029-09-30 |
| Phase | Phase 1 |
What NCT06904378 shows while recruiting
NCT06904378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT06904378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06904378 about?
NCT06904378 is a clinical study titled "ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma". 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-p...
What is the current status of trial NCT06904378?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2026-03-25. Estimated completion is 2029-09-30.
What interventions are being tested in trial NCT06904378?
The interventions under investigation include: Gemcitabine (DRUG), Nab paclitaxel (DRUG), ONT01 (DRUG).
Who is sponsoring clinical trial NCT06904378?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06904378's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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