First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL

  • STATUS
    Recruiting
  • End date
    Apr 13, 2024
  • participants needed
    57
  • sponsor
    Sanofi
Updated on 13 May 2022
lymphoma
multiple myeloma

Summary

Primary Objective:

To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D)

Secondary Objectives:

  • To characterize the safety profile of SAR442257
  • To characterize the pharmacokinetics (PK) profile of SAR442257
  • To evaluate the potential immunogenicity of SAR442257
  • To assess preliminary evidence of antitumor activity

Description

Study duration per participant is 2 months to estimated 16 months. Cycle lengths in this study are 27 days in Cycle 1 and 28 days for subsequent cycles as determined by totality of data collected thus far including PK/Pharmacodynamics (PD), safety and preliminary efficacy.

Details
Condition Neoplasm Malignant
Treatment SAR442257
Clinical Study IdentifierNCT04401020
SponsorSanofi
Last Modified on13 May 2022

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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