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news.Genmab has initiated a Phase I/II safety and dose finding study of HuMax-CD38 for the treatment of multiple myeloma. The study will include a maximum of 122 patients with multiple myeloma who are relapsed or refractory to at least two different prior treatments and are without further established treatment options.
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This open label dose escalation safety study will consist of two parts. In part I, 26 to 62 patients will be enrolled depending on the number of dose levels reached during escalation. Patients in part I will be divided into cohorts at various doses of HuMax-CD38, with each patient receiving 7 infusions. The first infusion will be followed by a 3 week period of safety monitoring with the following 6 doses to be given at weekly intervals.
In part II, 60 patients will be enrolled with 20 patients in each of three dose levels. The highest dose in part II will be the highest safe dose in part I and two dose levels below. Patients in part II will receive 6 infusions of HuMax-CD38 at weekly intervals.
In each part of the study, patients will attend 12 follow up visits at 2 to 4 week intervals to assess safety and efficacy and will be followed every 12 weeks thereafter until disease progression, initiation of alternative treatment for multiple myeloma (MM) or death for a maximum total of 2 years from study start.
HuMax-CD38 is a fully human antibody that targets the CD38 molecule which is highly expressed on the surface of multiple myeloma tumor cells.
Lisa Drakeman, CEO of Genmab, said: “We are looking forward to the results of this safety study and hope that HuMax-CD38 may one day offer a new potential treatment for multiple myeloma patients who have run out of treatment options.”