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Monoclonal Antibodies

Magrolimab for Brain Cancer (PNOC025 Trial)

Phase 1

Waitlist Available

Led By Sabine Mueller, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have measureable disease. Measurable disease will be defined as lesions that can be accurately measured in two dimensions (longest diameters to be recorded) with a minimum size of no less than double the slice thickness. Previously irradiated lesions are considered non-measurable except in cases of documented progression of the lesion since the completion of radiation therapy.

Creatinine clearance or radioisotope Glomerular filtration rate (GFR) >= 60 millilitre (mL) per minute (mL/min) 1.73 m2 or

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to magrolimab, Ferumoxytol, or iron contained drugs or supplements.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety of magrolimab, a drug that targets the protein CD47, in children and adults with recurrent or progressive brain tumors. Pre-clinical studies have shown that the drug can prolong survival in various types of brain tumors.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While Magrolimab has shown a good safety profile in previous studies, potential side effects may include allergic reactions similar to other drugs in its class, issues related to blood cells like anemia (low red blood cell count), or complications from activating the immune system against cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured by scans and is not just in previously treated areas.

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My kidney function, measured by creatinine clearance or GFR, is normal or near normal.

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I am between 2 and 6 years old with a creatinine level at or below 0.8 mg/dL.

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I am between 6 and 9 years old with a creatinine level at or below 1.0 mg/dL.

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I am between 10 and 12 years old with a creatinine level at or below 1.2 mg/dL.

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I am between 13 and 16 years old with a creatinine level below the gender-specific limit.

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I am 16 or older with a kidney function within the normal range.

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My brain tumor is aggressive and has come back or gotten worse.

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I had my last strong chemotherapy 3 weeks ago, or 6 weeks ago if it was with specific drugs.

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My bilirubin levels are within the normal range, or slightly higher if I have Gilbert's syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any ongoing serious illnesses or infections.

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

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I am not pregnant or breastfeeding.

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I haven't had chemotherapy in the last 3 weeks or radiotherapy in the last 12 weeks, and I've recovered from their side effects.

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I have tested positive for hepatitis B or C, but I am not currently infected with hepatitis C.

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I have not needed systemic treatment for an autoimmune disease in the last 2 years.

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I have been treated with drugs targeting CD47 or SIRPα.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with treatment-emergent adverse events

Recommended Phase 2 Dose (RP2D)

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782

67%

Abdominal pain

33%

Infusion related reaction

33%

Performance status decreased

33%

Pyrexia

33%

Pain

33%

Gait disturbance

33%

Hypotension

33%

Hyperhidrosis

33%

Gastrooesophageal reflux disease

33%

Headache

33%

Deafness

33%

Malignant neoplasm progression

33%

Vomiting

33%

Pollakiuria

33%

Diarrhoea

33%

Rash maculo-papular

33%

Lactic acidosis

33%

Nausea

33%

Aspartate aminotransferase increased

33%

Blood alkaline phosphatase increased

33%

Blood bilirubin increased

33%

Blood lactate dehydrogenase increased

33%

Mental disorder

33%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Magrolimab Priming Dose Only

Magrolimab 45 mg/kg

Magrolimab 10 mg/kg

Magrolimab 20 mg/kg

Magrolimab 30 mg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magrolimab

2022

Completed Phase 2

~220

0 / 17Eligibility criteria met