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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03860207|
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : November 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Osteosarcoma Other Solid Tumor Cancers||Biological: Humanized 3F8 Bispecific Antibody Other: Blood draw||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma, Osteosarcoma, and Other GD2(+) Solid Tumors|
|Actual Study Start Date :||February 22, 2019|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||February 2022|
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.
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 Name: Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb)
Other: Blood draw
In cycle 1, blood is drawn for PK studies.
- maximum tolerated dosage (MTD) Phase I [ Time Frame: Days 1 through 28 ]The MTD will be defined as the dose whose toxicity rate does not exceed an acceptable threshold of toxicity of 15%.Toxicity will be monitored using CTCAE version 4.0. DLT only during cycle 1, i.e. Days 1 through 28. Allowance will be made for the expected toxicities of hu3F8 from which hu3F8-BsAb was derived.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860207
|Contact: Shakeel Modak, MDfirstname.lastname@example.org|
|Contact: Brian Kushner, MD||212-639-6793|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Shakeel Modak, MD 212-639-7623|
|Contact: Brian Kushner, MD 212-639-6793|
|Principal Investigator: Shakeel Modak|
|Principal Investigator:||Shakeel Modak, MD||Memorial Sloan Kettering Cancer Center|