NCT02187848 (Clinical Trial/ SAR408701)

Study Title
Evaluation of SAR408701 in Patients With Advanced Solid Tumors (NCT02187848)

Trial Description
Primary Objectives:
To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Escalation Phase).
To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) of SAR408701 administered once every 2 weeks without a loading dose at Cycle 1.

Secondary Objectives:
To characterize the overall safety profile of SAR408701. To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives.
To identify the recommended phase 2 dose (RP2D) of SAR408701. To assess the potential immunogenicity of SAR408701.

This trial is sponsored by Sanofi®.

Study Data

  • Condition: Neoplasms
  • Interventions:
    • Drugs used in this trial
      • SAR408701
  • Phase: I & II
  • Enrollment: 152
  • Start: July 23, 2014
  • Estimated Completion: April 8, 2019
  • Last verified: May 2017
  • Last Updated: May 2017

Study Schematic

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Last Editorial review: September 2017
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.