20 November, 2018
Single-use technology, designed for the manufacturing of biopharmaceutical products, has made major inroads over the last 30 years. First introduced in the late 1970s in the form of disposable capsules and a ...
Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 (NCT02064387)
This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the therapeutic potential of GSK2857916 (J6M0-mcMMAF) in subjects with multiple myeloma (MM) and other hematologic malignancies that express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be safely administered to subjects 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 other BCMA positive hematologic malignancies. The study will consists of two parts: a Part 1 dose escalation phase and a Part 2 expansion phase for safety, and clinical activity testing. The study will enroll a total of approximately 80 subjects with relapsed/refractory MM or other BCMA-expressing hematologic malignancies.
This trial is sponsored by GlaxoSmithKline. 
Last Editorial review: November 2017
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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20 November, 2018
05 October, 2018
When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000, only a handful of patent applications claiming ADCs had been published. As research cont...