Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Osteosarcoma

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Gaucher Disease Type 2

Neuroepithelioma

Soft Tissue Sarcoma

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Immunoglobulins, Intravenous

Immunologic Factors

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.

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.

Humanized 3F8 Bispecific Antibody

In cycle 1, blood is drawn for PK studies.

Blood draw

The purpose of this study is to test the safety of a study drug called humanized 3F8 bispecific antibody (Hu3F8-BsAb).

This phase I/II trial will assess the toxicity and pharmacokinetics (PK) of the humanized anti-GD2 x anti-CD3 bispecific antibody (hu3F8-BsAb) in phase I and the anti-tumor activity of hu3F8-BsAb in phase II.

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

Summary of DLTs in DLT evaluable subjects.

Y-mAbs Therapeutics

The table shows TEAEs with onset prior to 31 days after last dose of Hu3F8-BsAb.

Treatment Emergent Adverse Event are either events with start date and time after initiation of treatment, or event that may have worsened on or after initiation of treatment. No patients experienced fatal AEs

Phase I Hu3F8-BsAb Dose level 1 (0.009 mcg/kg/cycle) is given IV over \~1-3 hours on Days 1 (0.0045 mcg/kg) and 8 (0.0045 mcg/kg) for each cycle.

0.009 mcg/kg/Cycle

Phase I Hu3F8-BsAb Dose level 2 (0.09 mcg/kg/cycle) is given IV over \~1-3 hours on Days 1 (0.045 mcg/kg) and 8 (0.045 mcg/kg) for each cycle.

0.09 mcg/kg/Cycle

Phase I Hu3F8-BsAb Dose level 3 (0.9 mcg/kg/cycle) is given IV over \~1-3 hours on Days 1 (0.45 mcg/kg) and 8 (0.45 mcg/kg) for each cycle.

0.9 mcg/kg/Cycle

Phase I Hu3F8-BsAb Dose level 4 (2.6 mcg/kg/cycle) is given IV over \~1-3 hours on Days 1 (1.3 mcg/kg) and 8 (1.3 mcg/kg) for each cycle.

2.6 mcg/kg/Cycle

Phase I Hu3F8-BsAb Dose level 5 (4.8 mcg/kg/cycle) is given IV over \~1-3 hours on Days 1 (1.3 mcg/kg) and 8 (3.5 mcg/kg) for each cycle.

4.8 mcg/kg/Cycle

Phase I Hu3F8-BsAb Dose level 6 (9.3 mcg/kg/cycle) is given IV over \~1-3 hours on Days 1 (1.3 mcg/kg) and 8 (8 mcg/kg) for each cycle.

9.3 mcg/kg/Cycle

Phase I Hu3F8-BsAb Dose level 2 (0.09 mcg/kg/cycle) is given IV over \~1-3 hours on Days 1 (0.045 mcg/kg) and 8 (0.45 mcg/kg) for each cycle.

Total

0- 6 years

7-11 years

12-17 years

18 years and above

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Disease Type

Safety Analysis Set.

In Protocol version 1.0 to 5.0 patients ≥ 1 year were eligible. In Protocol version 6.0 to 10.0 patients between ≥ 1 year and \< 18 years were eligible.

The study was terminated after 11 subjects due to a business strategy decision. At this point the maximum tolerated dose was not established.

Joris Wilms

Any DLT

DLT Type - Nervous system disorder

DLT Type - Syncope

Dose Limiting Toxicities (DLTs) Phase I

Dose Level 1 (0.009 mcg/kg/cycle) is the starting dose Phase I Hu3F8-BsAb Dose level 1 (0.009 mcg/kg/cycle) is given IV over \~1-3 hours on Days 1 (0.0045 mcg/kg) and 8 (0.0045 mcg/kg) for each cycle.

Spots Global Cancer Trial Database for 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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial