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
NCT03860207 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2023-09-13
Summary
The purpose of this study is to test the safety of a study drug called humanized 3F8 bispecific antibody (Hu3F8-BsAb).
Conditions
- Neuroblastoma
- Osteosarcoma
- Other Solid Tumor Cancers
Interventions
- BIOLOGICAL
-
Humanized 3F8 Bispecific Antibody
Phase I Hu3F8-BsAb is given IV over \~1-3 hours on Days 1 and 8 for each cycle.Phase II Hu3F8-BsAb is given IV over \~1-3 hours on Days 1 and 8 for each cycle.
- OTHER
-
Blood draw
In cycle 1, blood is drawn for PK studies.
Sponsors & Collaborators
-
Y-mAbs Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-22
- Primary Completion
- 2021-10-20
- Completion
- 2021-10-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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