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NCT04387071 · ClinicalTrials.gov registry record · Phase 1
CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma
A Phase 1 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04387071: Clinical Trial Phase 1 study, sponsored by University of Southern California.
NCT04387071 is a Phase 1 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04387071, a Phase 1 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This phase Ib/II trial studies the side effects and best dose of CMP-001 and how well it works when given together with INCAGN01949 in treating patients with stage IV pancreatic cancer and other cancers except melanoma. CMP-001 is made up of a short piece of DNA that is packaged in a protein, known as a virus-like particle (VLP). VLPs are detected and processed by cells of the immune system. The DNA contained in CMP-001 activates the immune system and recruit cells of the immune system to the tumor. INCAGN01949 is an antibody, a type of protein, which has been shown to stimulate the immune system. Injecting CMP-001 and INCAGN01949 directly into the tumor may work against tumor cells to slow tumor growth by causing tumor cells to die.
Primary Outcome
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Prog
Interventions
- BIOLOGICAL Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949
- DRUG VLP-encapsulated TLR9 Agonist CMP-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-04-29 |
| Est. Completion | 2022-12-28 |
| Phase | Phase 1 |
Why NCT04387071 stopped before completion
NCT04387071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949 is the first listed.
NCT04387071 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04387071 about?
NCT04387071 is a clinical study titled "CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma". This phase Ib/II trial studies the side effects and best dose of CMP-001 and how well it works when given together with INCAGN01949 in treating patients with stage IV pancreatic cancer and other cancers except melanoma. CMP-001 is made up of a short piece of DNA that is packaged in a protein, known ...
What is the current status of trial NCT04387071?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2021-04-29. Estimated completion is 2022-12-28.
What interventions are being tested in trial NCT04387071?
The interventions under investigation include: Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949 (BIOLOGICAL), VLP-encapsulated TLR9 Agonist CMP-001 (DRUG).
Who is sponsoring clinical trial NCT04387071?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04387071's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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