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Monoclonal Antibodies

Magrolimab + Dinutuximab for Relapsed Neuroblastoma and Osteosarcoma

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 up to 5 years post treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events (dose finding cohort)

Overall response rate (expansion cohort)

Secondary study objectives

Pharmacokinetics (PK) of Hu5F9-G4 (magrolimab)

Side effects data

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

67%

Abdominal pain

33%

Infusion related reaction

33%

Malignant neoplasm progression

33%

Performance status decreased

33%

Pyrexia

33%

Pain

33%

Gait disturbance

33%

Lactic acidosis

33%

Hypotension

33%

Hyperhidrosis

33%

Gastrooesophageal reflux disease

33%

Headache

33%

Deafness

33%

Vomiting

33%

Pollakiuria

33%

Diarrhoea

33%

Rash maculo-papular

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

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

2022

Completed Phase 2

~220