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NCT05169944 · ClinicalTrials.gov registry record · Phase 1
Magrolimab in Children and Adults With Recurrent or Progressive Malignant Brain Tumors
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT05169944: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT05169944 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05169944, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
Children and adults with recurrent or progressive malignant brain tumors have a dismal prognosis, and outcomes remain very poor. Magrolimab is a first-in-class anticancer therapeutic agent targeting the Cluster of differentiation 47 (CD47)-signal receptor protein-alpha (SIRP-alpha) axis. Binding of magrolimab to human CD47 on target malignant cells blocks the "don't eat me" signal to macrophages and enhances tumor cell phagocytosis. Pre-clinical studies have shown that treatment with magrolimab leads to prolonged survival in models of Atypical Teratoid Rhabdoid Tumors (ATRT), diffuse intrinsic pontine glioma (DIPG), high-grade glioma (adult and pediatric), medulloblastoma, and embryonal tumors formerly called Primitive Neuro-Ectodermal Tumors (PNET). Safety studies in humans have proven that magrolimab has an excellent safety profile. Ongoing studies are currently testing magrolimab in adult myelodysplastic syndromes, acute myeloid leukemia, non-Hodgkin lymphoma, colorectal, ovarian, and bladder cancers. Herein we propose to test the safety of magrolimab in children and adults with recurrent or progressive malignant brain tumors.
Primary Outcome
The investigator will employ the Bayesian optimal interval (BOIN) design to find the maximum tolerated dose (MTD). If the observed dose-limiting toxicity rate at the current dose is \<= 0.236, the next cohort of patients will be treated at the next higher dose level; if it is \>= 0.359, the next cohort of patients will be treated at the next lower dose level.
Interventions
- DRUG Magrolimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2022-04-22 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 1 |
What the finished NCT05169944 record still lists
NCT05169944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Magrolimab is the first listed.
NCT05169944 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05169944 about?
NCT05169944 is a clinical study titled "Magrolimab in Children and Adults With Recurrent or Progressive Malignant Brain Tumors". Children and adults with recurrent or progressive malignant brain tumors have a dismal prognosis, and outcomes remain very poor. Magrolimab is a first-in-class anticancer therapeutic agent targeting the Cluster of differentiation 47 (CD47)-signal receptor protein-alpha (SIRP-alpha) axis. Binding of ...
What is the current status of trial NCT05169944?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2022-04-22. Estimated completion is 2024-09-30.
What interventions are being tested in trial NCT05169944?
The interventions under investigation include: Magrolimab (DRUG).
Who is sponsoring clinical trial NCT05169944?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05169944's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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