Phase 1 Study of GSK2857916 in Subjects with Haematologic Malignancies
Research type
Research Study
Full 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 Haematologic Malignancies Expressing BCMA
IRAS ID
147173
Contact name
Kwee Yong
Contact email
Eudract number
2013-004549-18
Clinicaltrials.gov Identifier
Research summary
Multiple Myeloma (MM) accounts for 1% of all cancers and for 10% of all haematological malignancies. Recent progress in understanding the biology of the disease has resulted in significant improvements in treatment strategies for MM. Unfortunately, duration of response and response rates decline dramatically in each subsequent line of treatment for this malignancy. MM remains incurable and the need for new treatment modalities is well recognised.
B-cell maturation antigen (BCMA) is expressed in various B-cell malignancies, including MM. The expression levels in MM vary from patient to patient, but GSK studies demonstrate that all patients tested express detectable levels of BCMA protein on their tumour cells. BCMA is selectively expressed on myeloma plasma cells and other B-cell malignancies, making it an attractive target for therapy.
GSK2857916 is a humanised immunoglobulin antibody drug conjugate, which binds specifically to BCMA. The hypothesis for this trial is that GSK2857916 can be safely administered to subjects with BCMA positive malignancies, at doses where target engagement can be demonstrated. In doing so, this study will determine if adequate target engagement of BCMA receptors proves to be safe and translates into clinical benefit for subjects with MM and other BCMA positive haematological malignancies.
This study is an open-label, dose escalation, Phase I, First Time in Human trial to establish safety and determine recommended phase 2 dosing regimen of GSK2857916. The trial will consist of two parts and enrol approximately 80 subjects (from US, UK and Canada). Approximately 14 patients are expected from the UK. The part 1 dose escalation phase will characterise safety and tolerability of GSK2857916. Part 2 will explore the safety, tolerability, pharmacokinetic, pharmacodynamic and clinical activity of the recommended phase 2 dose and schedule of GSK2857916 identified in Part 1.
Establishing the safety of GSK2857916 will be the primary objective of this study.
REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/0712
Date of REC Opinion
13 Jun 2014
REC opinion
Further Information Favourable Opinion