Magrolimab + Dinutuximab for Relapsed Neuroblastoma and Osteosarcoma

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byRobbie G Majzner

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial is to find out the best dose, possible benefits and/or side effects of magrolimab in combination with dinutuximab in treating patients with neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory) 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. In addition, this trial may help researchers find out if it is safe to give magrolimab and dinutuximab after surgery to remove tumors from the lungs.

Research Team

Robbie G Majzner

Principal Investigator

Cancer Immunotherapy Trials Network

Eligibility Criteria

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.

Inclusion Criteria

If you have osteosarcoma, it must be big enough to measure accurately with a CT scan, MRI, or calipers. A chest x-ray cannot be used to determine eligibility.

You have a type of cancer called high-risk neuroblastoma or osteosarcoma, and your cancer has either come back after previous treatment, is not responding to treatment, or there are no other treatments available that can cure your cancer.

Female patients of childbearing potential must not be nursing or planning to be pregnant and must have a negative urine or serum pregnancy test within 30 days before enrollment and within 72 hours before the first administration of study treatment

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Exclusion Criteria

You are pregnant.

You have an ongoing and uncontrolled health problem.

You are currently taking part in another study for an experimental drug.

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Treatment Details

Interventions

Dinutuximab (Monoclonal Antibodies)
Magrolimab (Monoclonal Antibodies)

Trial OverviewResearchers 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.

Participant Groups

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.