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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 is a Phase 1 study that was terminated before completion, run by HiberCell. The registered enrollment target is 5 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05484011
The ClinicalTrials.gov registry entry for NCT05484011 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HiberCell, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CDX-1140 is the first listed.
NCT05484011 reports 0 study locations.
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.
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