Key Highlights

Risk & Performance

Pipeline Risk Assessment

Pipeline Risk Assessment

Based on historical performance

High Risk

Score: 80/100

Failure Rate

41.9%

13 terminated/withdrawn out of 31 trials

Success Rate

27.8%

-58.8% vs industry average

Late-Stage Pipeline

0%

0 trials in Phase 3/4

Results Transparency

120%

6 of 5 completed trials have results

Key Signals

5 recruiting6 with results10 terminated

Enrollment Performance

Analytics

Phase 1
18(60.0%)
Phase 2
10(33.3%)
N/A
1(3.3%)
Early Phase 1
1(3.3%)
30Total
Phase 1(18)
Phase 2(10)
N/A(1)
Early Phase 1(1)

Activity Timeline

Global Presence

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Clinical Trials (31)

Showing 20 of 31 trials
NCT07537400Phase 2Recruiting

Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5

Role: collaborator

NCT05489887Phase 2Recruiting

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

Role: collaborator

NCT00911560Phase 1Completed

Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma

Role: collaborator

NCT02502786Phase 2Active Not Recruiting

Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

Role: collaborator

NCT03363373Phase 2Active Not Recruiting

Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Role: lead

NCT04743661Phase 2Active Not Recruiting

131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma

Role: collaborator

NCT04022213Phase 2Active Not Recruiting

A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum

Role: collaborator

NCT07027748Phase 1Recruiting

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

Role: collaborator

NCT07698899Phase 1Recruiting

A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)

Role: collaborator

NCT07011654Phase 1Recruiting

Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

Role: collaborator

NCT03189706Early Phase 1Active Not Recruiting

Study of Chemoimmunotherapy for High-Risk Neuroblastoma

Role: collaborator

NCT05130255Phase 1Terminated

GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

Role: lead

NCT05994157Phase 1Terminated

Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma

Role: lead

NCT01757626Phase 1Active Not Recruiting

Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma

Role: collaborator

NCT02307630Not ApplicableActive Not Recruiting

PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study

Role: collaborator

NCT03033303Phase 2Completed

A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma

Role: collaborator

NCT05064306Unknown

131I-omburtamab for the Treatment of Central Nervous System/Leptomeningeal Neoplasms in Children and Young Adults

Role: collaborator

NCT02650648Phase 1Completed

Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma

Role: collaborator

NCT04560166Phase 2Terminated

Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma

Role: lead

NCT03275402Phase 2Terminated

131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases

Role: lead