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NCT05484011 · ClinicalTrials.gov registry record · Phase 1
A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1 study, sponsored by HiberCell.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT05484011: Clinical Trial Phase 1 study, sponsored by HiberCell.
NCT05484011 is a Phase 1 study that was terminated before completion, run by HiberCell. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05484011, a Phase 1 study, was terminated before completion, sponsored by HiberCell.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The primary objective of this maintenance therapy study is to identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of odetiglucan in combination with CDX-1140 in patients with metastatic PDAC with evidence of response or stable disease following a minimum of 16 and no more than 32 weeks of chemotherapy. Up to 45 patients will be enrolled and dosed (30 patients in Part A and 15 in Part B).
Primary Outcome
Determination of MTD of odetiglucan + CDX-1140
Interventions
- BIOLOGICAL CDX-1140
- BIOLOGICAL odetiglucan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2024-03-04 |
| Phase | Phase 1 |
Why NCT05484011 stopped before completion
NCT05484011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which CDX-1140 is the first listed.
NCT05484011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05484011 about?
NCT05484011 is a clinical study titled "A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma". The primary objective of this maintenance therapy study is to identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of odetiglucan in combination with CDX-1140 in patients with metastatic PDAC wit...
What is the current status of trial NCT05484011?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2022-12-15. Estimated completion is 2024-03-04.
What interventions are being tested in trial NCT05484011?
The interventions under investigation include: CDX-1140 (BIOLOGICAL), odetiglucan (BIOLOGICAL).
Who is sponsoring clinical trial NCT05484011?
This trial is sponsored by HiberCell, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05484011's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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