top of page
  • Completed

NCT02064387: Phase 1 -Safety Pharm.kinetics Pharm.dynamics Img. & Cl. Activity GSK2857916 - DREAMM-1

Updated: Sep 19, 2022

DREAMM-1 study

dreamm1

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916


This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and lymphomas that express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be safely administered to subjects with MM and with BCMA positive malignancies at doses where target engagement can be demonstrated.


This study will determine if adequate target engagement of BCMA receptors translates into clinical benefit for subjects with MM and BCMA positive lymphomas. The study will consists of two parts: a Part 1 dose escalation phase and a Part 2 expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The study will enroll a total of approximately 80-95 subjects with relapsed/refractory MM or BCMA-expressing hematologic malignancies. The maximum dose to be administered in this trial will not exceed 5 milligram/kilogram(mg/kg).


Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916


Sponsor

 

ClinicalTrials.gov Identifier: NCT02064387

Official Title: A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of the Antibody Drug Conjugate GSK2857916 in Subjects With Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA

Click here to see details on ClinicalTrials.gov


 

 

Drug: GSK2857916

 

Targeting B-cell maturation antigen with GSK2857916 antibody-drug conjugate in relapsed or refractory multiple myeloma (BMA117159): a dose escalation and expansion phase 1 trial

PMID: 30442502; Lancet Oncol; Dec 2018

Click here to see the details.

 

Locations

United States, Massachusetts

United States, New York

United States, North Carolina

United States, Pennsylvania

United States, Texas

United States, Washington

Canada, British Columbia

Canada, Ontario

Europe

United Kingdom

 

RELATED POSTS


DREAMM-1

NCT02064387: Phase 1 -Safety Pharm.kinetics Pharm.dynamics Img. & Cl. Activity GSK2857916 - DREAMM-1


DREAMM-2

NCT03525678: Phase 2 - Two Doses of GSK2857916 in Myeloma who have failed Anti-CD38 Ab. DREAMM 2


DREAMM-3

NCT04162210: Phase 3 - Belantamab Mafodotin Vs Pomalidomide + Low-dose Dexamethasone (Pom/Dex) RRMM


DREAMM-4

NCT03848845: Phase 1/2: GSK2857916 in Combination With Pembrolizumab in RRMM Myeloma- DREAMM 4


DREAMM-5

NCT04126200: Phase 1/2 - Belantamab Mafodotin as Monotherapy & With Anti-cancer Rx (RRMM) (DREAMM 5)


DREAMM-6

NCT03544281: Phase 2: GSK2857916 /Len/Dex Vs GSK2857916/Bortezomib/Dex - RRMM Myeloma - DREAMM 6


DREAMM-7

NCT04246047: Phase 3: Belantamab Mafodotin, Bortezomib and Dex RRMM Myeloma (DREAMM 7)


DREAMM-8

NCT04484623: Phase 3 - Belantamab Mafodotin & Pom/Dex (Pd) Vs Bortezomib & Pd in Ref. MM (DREAMM 8)


DREAMM-9

NCT04091126: Phase 1 - Belantamab Mafodotin + Standard of Care New Multiple Myeloma (DREAMM 9) NDMM

DREAMM-12

NCT04398745: Phase 1: Belantamab Mafodotin With Normal and Varying Degree of Impaired Renal Function


DREAMM-13

NCT04398680: Phase 1: Belantamab Mafodotin With Normal & Impaired Hepatic Function (DREAMM 13) RRMM


DREAMM-14

NCT05064358: Phase 2 - Alternative Dosing Regimens of Belantamab Mafodotin RRMM - (DREAMM 14)

 

NCT038282: Phase 1 - Dose Esc Study Belantamab mafodotin (GSK2857916) in Japanese With Refr MM


NCT03715478: Phase 1/2: Multi-Center Study of GSK2857916 With Pomalidomide & Dex - Algonquin trial


NCT04680468: Belantamab Mafodotin as Pre- and Post-autologous Stem Cell Transplant & Maintenance


NCT04822337: Phase 1/2 - Study of Carfilzomib, Len, Dex & Belantamab Mafodotin in Multiple Myeloma


NCT04802356: Phase 2: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma


NCT04808037: Phase 1/2: Blmf, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM (BelaRd)


NCT05060627: Phase 1/2: Belantamab Mafodotin + Kd RRMM Multiple Myeloma, Refractory to Lenalidomide


AMaRC 19-02 - BelaCarD - Phase I/II - Study of combination belantamab maf, carfilzomib, Dex RRMM


NCT03732703: Phase 1/2: Myeloma-Developing Regimens Using Genomics (MyDRUG)








Commentaires


Posts Archive
bottom of page