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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
PNOC025 Trial 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.Check my eligibility
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.See study design
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.
PNOC025 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
PNOC025 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with treatment-emergent adverse events
Recommended Phase 2 Dose (RP2D)
Side effects data
From 2020 Phase 1 & 2 trial • 78 Patients • NCT0295378267%
Dry skin
44%
Diarrhoea
44%
Dermatitis acneiform
44%
Fatigue
44%
Lymphocyte count decreased
33%
Infusion related reaction
33%
Abdominal pain
22%
Myalgia
22%
Decreased appetite
22%
Small intestinal obstruction
22%
Tinnitus
22%
Nausea
22%
Chills
22%
Oedema peripheral
22%
Back pain
22%
Headache
22%
Pruritus
22%
Dehydration
22%
Rash maculo-papular
11%
Hypokalaemia
11%
Dyspepsia
11%
Tumour pain
11%
Hypertension
11%
Dyspnoea
11%
Lymphopenia
11%
Malignant neoplasm progression
11%
Cerebrovascular accident
11%
Anaemia
11%
Palpitations
11%
Conjunctivitis allergic
11%
Dry eye
11%
Abdominal distension
11%
Constipation
11%
Gastrooesophageal reflux disease
11%
Hypoaesthesia oral
11%
Folliculitis
11%
Sinusitis
11%
Gastrointestinal stoma complication
11%
Aspartate aminotransferase increased
11%
Blood bilirubin increased
11%
Hypomagnesaemia
11%
Hypophosphataemia
11%
Dizziness
11%
Confusional state
11%
Depression
11%
Haematuria
11%
Dysphonia
11%
Ingrowing nail
11%
Skin infection
11%
Tinea cruris
11%
Platelet count decreased
11%
Alanine aminotransferase increased
11%
Photopsia
11%
Conjunctivitis
11%
Gastroenteritis viral
11%
Hyperglycaemia
11%
Arthralgia
11%
Neck pain
11%
Somnolence
11%
Nasal congestion
11%
Deep vein thrombosis
11%
Oesophageal pain
11%
Vomiting
11%
Chest discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Magrolimab 10 mg/kg
Magrolimab 20 mg/kg
Magrolimab 30 mg/kg
Magrolimab 45 mg/kg
Magrolimab Priming Dose Only
PNOC025 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
2021
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,447 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,817 Total Patients Enrolled
Sabine Mueller, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
5 Previous Clinical Trials
531 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hemoglobin level is at least 9.5 g/dL, possibly after receiving a blood transfusion.I do not have any ongoing serious illnesses or infections.I have had at least one treatment for my condition and have recovered from its immediate side effects.I am allergic to magrolimab, Ferumoxytol, or similar iron drugs.I have not had hemolytic anemia or Evans Syndrome in the last 3 months.I needed more than 2 blood transfusions in the last month.My cancer can be measured by scans and is not just in previously treated areas.My brain and nerves are working well.I will discuss my last biologic treatment with the Study Chair due to its long-lasting effects.I have had a bone marrow transplant.I have received previous treatments for my condition.I am mostly active and can take care of myself despite my age.I have a tumor in the middle of my brain or spinal cord, and it may have spread.I have not needed systemic treatment for an autoimmune disease in the last 2 years.It has been over 3 months since my last stem cell transplant.I had my last strong chemotherapy 3 weeks ago, or 6 weeks ago if it was with specific drugs.I've been on a stable or reducing dose of corticosteroids for at least a week.I've had no recent side effects from biological therapy, last dose was over a week ago.It's been over 28 days or 4 half-lives since my last monoclonal antibody treatment.My platelet count is at least 100,000/mm3 without transfusions for 7 days.My kidney function, measured by creatinine clearance or GFR, is normal or near normal.My kidney function, based on my age and gender, is within the required range.I am between 2 and 6 years old with a creatinine level at or below 0.8 mg/dL.I am between 6 and 9 years old with a creatinine level at or below 1.0 mg/dL.I am between 10 and 12 years old with a creatinine level at or below 1.2 mg/dL.I am between 13 and 16 years old with a creatinine level below the gender-specific limit.I am 16 or older with a kidney function within the normal range.I am not pregnant or breastfeeding.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.I have tested positive for hepatitis B or C, but I am not currently infected with hepatitis C.I have been treated with drugs targeting CD47 or SIRPα.My organs are functioning well.I am currently receiving or have received radiation therapy.My last radiation treatment was 3 months ago or more.I had my last full-body or brain and spine radiation treatment over 12 weeks ago.My kidney function is normal.I received my last radiation treatment at least 14 days ago.My brain tumor is aggressive and has come back or gotten worse.I am currently taking corticosteroids.My bone marrow is functioning well.My bilirubin levels are within the normal range, or slightly higher if I have Gilbert's syndrome.My kidney function, measured by creatinine levels, fits the required range.My liver is working well.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Magrolimab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What further experiments have been performed with Magrolimab?
"Magrolimab was first researched at the NIH's Clinical Center/ National Cancer Institute in 2016. Since then, there have been 5 completed clinical trials and 16 additional studies recruiting patients in a variety of locations including San Francisco, California."
Answered by AI
To what extent is this clinical trial being utilized by patients?
"Affirmative. Clinicaltrials.gov records show that this medical study, initially posted on April 22nd 2022, is presently seeking participants. 24 individuals are needed across 3 locations for the trial's commencement."
Answered by AI
Is this research pioneering in its field?
"Gilead Sciences has sponsored a total of 5 Magrolimab clinical trials since the initial study in 2016, involving 178 patients across 26 countries and 124 cities. Currently, 16 active studies are running worldwide."
Answered by AI
Are any more participants being taken on for this clinical trial?
"Affirmative. Clinicaltrials.gov data indicates that, as of October 26th 2022, this clinical trial is still actively recruiting patients to become part of the study which was launched on April 22nd 2022. 24 individuals are needed from 3 distinct sites for participation."
Answered by AI
Are there any safety concerns associated with Magrolimab treatment?
"The safety of Magrolimab is assessed to be a 1 due to its status as a Phase 1 trial, signifying that there are limited data regarding both it's efficacy and safety."
Answered by AI
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