Title: Phase I/II study of humanized 3F8 bispecific antibody (Hu3F8-BsAb) in patients with relapsed/refractory neuroblastoma, osteosarcoma, and other GD2(+) solid tumors
Principal Investigator: Shakeel Modak, MD, of Memorial Sloan Kettering Cancer Center in New York, New York
Description: Researchers are conducting a phase 1/2 trial to test a humanized 3F8 bispecific antibody (Hu3F8-BsAb, nivatrotamab) in pediatric patients with relapsed/refractory neuroblastoma, osteosarcoma, and other GD2-positive solid tumors.
Researchers will assess toxicity and pharmacokinetics in phase 1 and the antitumor activity of nivatrotamab in phase 2.
In both phases, patients will receive nivatrotamab intravenously over 1 to 3 hours on days 1 and 8 of each cycle. The primary outcome in phase 1 is the maximum tolerated dose.
This trial is enrolling patients aged 1 to 17 years. To be eligible for phase 1, patients must have a histologically confirmed diagnosis of neuroblastoma, brain metastasis plus high urine catecholamine levels, high grade osteosarcoma, or another GD2-expressing solid tumor. For a full list of eligibility criteria, please see the reference.
This study is sponsored by Y-mAbs Therapeutics.
ClinicalTrials.gov. 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. Accessed June 17, 2022.