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Monoclonal Antibodies

Magrolimab for Neuroblastoma

Phase 1
Waitlist Available
Led By Robbie G Majzner
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of hu5f9-g4 (magrolimab) until the earliest of: death, local recurrence, new metastatic disease, progression of metastatic disease or secondary malignancy, or date of last contact, assessed up to 5 years
Awards & highlights

Study Summary

This trial is to find out the benefits and side effects of magrolimab and dinutuximab for treating patients with relapsed neuroblastoma or relapsed osteosarcoma. Magrolimab and dinutuximab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. The combination of magrolimab and dinutuximab may shrink or stabilize relapsed or refractory neuroblastoma or relapsed osteosarcoma.

Who is the study for?
This trial is for patients with neuroblastoma or osteosarcoma that has returned or isn't responding to treatment. It's open to various ages, depending on the arm of the study (up to 18 years for Arm A and up to 35 years for Arm B). Participants need a certain level of physical fitness, adequate organ function, and cannot be pregnant. They must not have had certain treatments recently and agree to use contraception.Check my eligibility
What is being tested?
Researchers are testing magrolimab combined with dinutuximab in this phase I trial. These drugs are designed to stop tumor cells from growing and spreading. The goal is to find the safest dose that might also shrink or stabilize cancer in patients who've had surgery or whose disease has come back after previous treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (due to monoclonal antibodies), infusion-related reactions, fatigue, blood disorders like anemia, increased risk of infections, and potential allergic responses similar in nature to other compounds used in this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose of hu5f9-g4 (magrolimab) until the earliest of: death, local recurrence, new metastatic disease, progression of metastatic disease or secondary malignancy, or date of last contact, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of hu5f9-g4 (magrolimab) until the earliest of: death, local recurrence, new metastatic disease, progression of metastatic disease or secondary malignancy, or date of last contact, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (dose finding cohort)
Incidence of adverse events (expansion cohort)
Overall response rate (expansion cohort)
+1 more
Secondary outcome measures
Anti-tumor activity
Event free survival
Pharmacokinetics (PK) of Hu5F9-G4 (magrolimab)

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782
67%
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%
Dyspnoea
11%
Hypertension
11%
Lymphopenia
11%
Tumour pain
11%
Dyspepsia
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (magrolimab, dinutuximab, surgery)Experimental Treatment8 Interventions
Patients receive magrolimab IV and dinutuximab IV on study. Patients with pulmonary osteosarcoma may undergo surgical resection of tumor after cycle 1. After surgery, these patients continue receiving magrolimab and dinutuximab on study. Patients also undergo CT, MRI, and collection of blood samples on study, as well as bone marrow aspiration and biopsy throughout the trial.
Group II: Arm A (magrolimab, dinutuximab)Experimental Treatment7 Interventions
Patients receive magrolimab IV and dinutuximab IV on study. Patients also undergo CT, MRI, and blood sample collection on study, as well as bone marrow aspiration and biopsy throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Magrolimab
2021
Completed Phase 2
~210
Biospecimen Collection
2004
Completed Phase 2
~1720
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Dinutuximab
2009
Completed Phase 3
~710
Resection
2023
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,282 Total Patients Enrolled
205 Trials studying Neuroblastoma
53,602 Patients Enrolled for Neuroblastoma
Robbie G MajznerPrincipal InvestigatorCancer Immunotherapy Trials Network
~55 spots leftby Dec 2032
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