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Monoclonal Antibodies
Study of the Safety and Efficacy of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma, Osteosarcoma and Other Solid Tumor Cancers
Phase 1 & 2
Waitlist Available
Research Sponsored by Y-mAbs Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 through 28 in cycle 1
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new protein drug that helps the body's defense system find and destroy harmful cells. It is likely aimed at patients who need new treatment options, possibly those with certain types of cancer.
Eligible Conditions
- Neuroblastoma
- Osteosarcoma
- Solid Tumor Cancers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1 through 28 in cycle 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 through 28 in cycle 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Limiting Toxicities (DLTs) Phase I
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: Hu3F8-BsAbExperimental Treatment2 Interventions
Phase I Hu3F8-BsAb is given IV over \~1-3 hours on Days 1 and 8 for each cycle. In cycle 1, blood is drawn for PK studies.Phase II Hu3F8-BsAb is given IV over \~1-3 hours on Days 1 and 8 for each cycle.
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Who is running the clinical trial?
Y-mAbs TherapeuticsLead Sponsor
25 Previous Clinical Trials
1,545 Total Patients Enrolled
13 Trials studying Neuroblastoma
1,240 Patients Enrolled for Neuroblastoma