Table 2.
Currently ongoing clinical trials of anti-GD2 mAbs.
| Tumor(s) | Study description and status |
|---|---|
| ch14.18 (dinutuximab) | |
| Neuroblastoma | Phase I study of 131I-MIBG + dinutuximab to determine a recommended phase II pediatric dose; currently recruiting; last updated September 2018 (NCT03332667) |
| Neuroblastoma | Phase II study to evaluate dinutuximab + cytokines (GM-CSF and IL-2) in high-risk patients; active, not recruiting; last updated July 2018 (NCT02169609) |
| Neuroblastoma | Phase I study of lenalidomide + dinutuximab ± isotretinoin for relapsed/refractory neuroblastoma; active, not recruiting; last updated October 2019 (NCT01711554) |
| Neuroblastoma | Phase I study to determine the maximum tolerated dose of expanded NK cells + dinutuximab in relapsed/recurrent neuroblastoma; recruiting; last updated May 2019 (NCT02573896) |
| Neuroblastoma | Phase II study of irinotecan + temozolomide + dinutuximab ± eflornithine in relapsed/refractory neuroblastoma; recruiting; last updated September 2019 (NCT 03794349) |
| Neuroblastoma | Phase II study of dinutuximab + sargramostim + combination chemotherapy in newly diagnosed high-risk neuroblastoma undergoing stem cell transplant; recruiting; last updated October 2019 (NCT03786783) |
| Osteosarcoma | Phase II study of dinutuximab + sargramostim in recurrent osteosarcoma; active, not recruiting; last updated October 2019 (NCT02484443) |
| hu14.18K322A | |
| Neuroblastoma | Phase II study of therapy for children with advanced stage neuroblastoma; last updated October 2019 (NCT01857934) |
| Neuroblastoma, osteosarcoma, melanoma, Ewing family of tumors | Observational study of pretreatment anti-therapeutic antibodies (anti-hu14.18K322A antibodies as detected by the human anti-human antibodies [HAHA] test); last updated January 2020 (NCT02159443) |
| hu3F8 | |
| Neuroblastoma | Phase I study of humanized anti-GD2 antibody hu3F8 and allogeneic natural killer cells for high-risk neuroblastoma; last updated October 2019 (NCT02650648) |
| Neuroblastoma | Phase II study of naxitamab (hu3F8) for high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow; last updated January 2020 (NCT03363373) |
| Neuroblastoma | Phase I/II study of combination therapy of antibody hu3F8 with GM-CSF in patients with relapsed/refractory high-risk neuroblastoma; last updated November 2019 (NCT01757626) |
| Neuroblastoma | Phase II study of monoclonal antibody 3F8 and sargramostim in treating patients with neuroblastoma; last updated October 2019 (NCT00072358) |
| Osteosarcoma | Phase II study of humanized monoclonal antibody 3F8 (hu3F8) with GM-CSF in the treatment of recurrent osteosarcoma; last updated January 2020 (NCT02522786) |
| 3F8 | |
| Neuroblastoma | Phase I study of beta-glucan and monoclonanal antibody 3F8 in treating patients with metastatic neuroblastoma; last updated February 2019 (NCT00492167) |
| Neuroblastoma | Phase 2 study of 131I-mAb 3F8 in treating patients with central nervous system cancer or leptomeningeal cancer; last updated October 2019 (NCT00445965) |
| ch14.18/CHO (dinutuximab beta) | |
| Neuroblastoma | Phase I study of investigational medicinal products in children with relapsed/refractory neuroblastoma; last updated July 2019 (NCT02914405) |
| Neuroblastoma | Phase III study of high-risk neuroblastoma 1.8 of SIOP-Europe (SIOPEN); last updated June 2018 (NCT01704716) |
GM-CSF, granulocyte-macrophage colony-stimulating factor; IL-2, interleukin-2; mAb, monoclonal antibody; MIBG, metaiodobenzylguanidine; NK, natural killer.