- Active, not recruiting
NCT038282: Phase 1 - Dose Esc Study Belantamab mafodotin (GSK2857916) in Japanese With Refr MM
Updated: Sep 19, 2022
NCT038282: Phase 1 - Dose Esc Study Belantamab mafodotin (GSK2857916) in Japanese With Refr MM
Belantamab mafodotin (GSK2857916) is a first in class, antibody dependent cellular cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug conjugate (ADC) which binds specifically to B cell maturation antigen (BCMA) expressed on tumor cells of all participants with multiple myeloma. This is a Phase 1, open label, dose escalation study to investigate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and clinical activity of GSK2857916 when given as monotherapy (Part 1) or given as combination therapy (Part 2). Dose escalation will follow a 3+3 design.
An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments
Sponsor:
Japanese Study
ClinicalTrials.gov Identifier: NCT03828292
Official Title: A Phase I Open-Label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of the Antibody Drug Conjugate GSK2857916 in Japanese Participants With Relapsed/Refractory Multiple Myeloma
First Posted : February 4, 2019
Click here for details on ClinicalTrials.gov
Bortezomib : National Cancer Institute
Bortezomib : MedlinePlus Drug Information
Dexamethasone : National Cancer Institute
Dexamethasone : MedlinePlus Drug Information
Belantamab mafodotin : National Cancer Institute
Belantamab mafodotin : MedlinePlus Drug Information
Pomalidomide : National Cancer Institute
Pomalidomide : MedlinePlus Drug Information
Location
Japan
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