NCT03860207

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 I/II Study of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma, Osteosarcoma, and Other GD2(+) Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Y-mAbs Therapeutics · Industry
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-02-22
• Primary completion: 2021-10-20
• Completion: 2021-10-20
• First posted: 2019-03-01
• Last updated: 2023-09-13
• Results posted: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study