HuMax-CD38 Enters Phase I/II Trial

Danish drugmaker Genmab has started a Phase I/II study of HuMax-CD38 for the treatment of multiple myeloma.

The open-label, dose-escalation study will consist of two parts. The 26–62 patients in Part 1 will be divided into cohorts at various doses of HuMax-CD38 with each patient receiving seven infusions.

In Part 2, 60 patients will be enrolled in one of three dosage groups. The highest dose in Part 2 will be the highest safe dose determined in Part 1.

In each part of the study, patients will attend 12 follow-up visits at two- to four-week intervals to assess safety and efficacy and will be followed every 12 weeks thereafter until disease progression, initiation of alternative treatment or death, Genmab said.