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Y-Mabs Therapeutics (YMAB)
NASDAQ:YMAB
Cd38-Sada:177Lu-Dota Complex
Non-Hodgkin Lymphoma
Phase I
Recruiting
Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma
Aug 08, 2023
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Gd2-Sada:177Lu-Dota Complex
Sarcoma, Malignant Melanoma, Sclc, High Risk Neuroblastoma
Phase I
Recruiting
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Nov 11, 2021
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Cd33*Cd3 Bsab
Aml, Childhood
Phase I
Terminated
A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sep 30, 2021
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Gm-Csf, Isotretinoin, Naxitamab
Neuroblastoma
Phase II
Withdrawn
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
May 27, 2021
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Nivatrotamab
Sclc
Phase I/II
Terminated
Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer
Feb 06, 2021
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Naxitamab And Gm-Csf In Combination With Irinotecan And Temozolomide
Neuroblastoma Recurrent
Phase II
Terminated
Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma
Sep 17, 2020
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131I-Omburtamab, Convention Enhanced Delivery
Dipg
Phase I
Withdrawn
131I-omburtamab Delivered by Convection-Enhanced Delivery in Patients With Diffuse Intrinsic Pontine Glioma
Sep 16, 2020
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Radiolabeled Dpta-Omburtamab
Solid Tumor, Adult, Leptomeningeal Metastasis
Phase I/II
Withdrawn
177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melanoma)
Mar 12, 2020
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177Lu-Dtpa-Omburtamab
Medulloblastoma, Childhood
Phase I/II
Terminated
177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma
Nov 11, 2019
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Blood Draw, Humanized 3F8 Bispecific Antibody
Osteosarcoma, Neuroblastoma, Other Solid Tumor Cancers
Phase I/II
Terminated
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
Feb 28, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Y-Mabs Therapeutics (YMAB) have in its pipeline
YMAB is currently developing the following drugs: Cd38-Sada:177Lu-Dota Complex, Gd2-Sada:177Lu-Dota Complex, Cd33*Cd3 Bsab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.