An Open-label, First-in-human, Single Agent, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of SAR442085 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

Protocol No
SANOFI-TED16132
Principal Investigator
Saurabh Chhabra
Phase
I
Summary
SAR442085 is an antibody. An antibody is a protein produced in the blood to fight diseases by attacking and killing harmful foreign organisms such as bacteria and viruses, and also attacking and killing cancer cells. SAR442085 belongs to a category of antibodies called “monoclonal antibodies CD38 Receptors: CD38 monoclonal antibodies that bind to the antigen by interrupting CD38 functions and cause cell death. CD38 monoclonal antibodies are used to treat multiple myeloma.
Description
The purpose of the escalation phase is to determine the maximum tolerated dose and to determine the recommended dose that is to be used in the expansion phase (Part B) of the study. In the escalation phase, the study will determine the best dose level which will minimize the risk of side effects during testing.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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