Magrolimab for Brain Cancer
(PNOC025 Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen bySabine Mueller, MD, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for children and adults with recurrent or progressive malignant brain tumors, including certain high-grade tumors. Participants must have failed at least one prior therapy and should not have received recent chemotherapy or radiotherapy. They need to be stable on corticosteroids if used, have sufficient organ function, and a performance score indicating they can perform daily activities.

Inclusion Criteria

My hemoglobin level is at least 9.5 g/dL, possibly after receiving a blood transfusion.

I have had at least one treatment for my condition and have recovered from its immediate side effects.

Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase ≤ 2.5x ULN.

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Exclusion Criteria

I do not have any ongoing serious illnesses or infections.

I am allergic to magrolimab, Ferumoxytol, or similar iron drugs.

Participants at risk for imminent herniation, clinical evidence of significant increased intracranial pressure, or with >1 cm midline shift.

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Treatment Details

Interventions

Magrolimab (Monoclonal Antibodies)

Trial OverviewThe trial is testing Magrolimab, an anticancer drug that targets the CD47-SIRP-alpha axis to enhance tumor cell destruction by the immune system. It's designed for those with specific malignant brain tumors who've seen their disease return or worsen despite treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (Magrolimab)Experimental Treatment1 Intervention

Each participant will receive magrolimab intravenously (IV) at a priming dose of 1 mg/kg during Cycle 0, followed by either 30 mg/kg or 45mg mg/kg dose weekly for eight weeks (Cycles 1 and 2), followed by either 30 mg/kg or 45 mg/kg dose every two weeks for the remainder of the study.