Clinical Trial

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

Terminated Phase 1
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Why the trial stopped
Sponsor decision based on limited clinical benefit observed in both Multiple Myeloma and Non-Hodgkin Lymphoma cohorts
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 relapsed 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 assess preliminary evidence of antitumor activity
Protocol Amendment History 3 changes
critical Trial status changed: Completed → Terminated 2026-08-15
critical Trial terminated: Sponsor decision based on limited clinical benefit observed in both Multiple Myeloma and Non-Hodgkin Lymphoma cohorts 2026-08-15
critical Trial completed 2026-05-30
Trial Details
NCT Number NCT04401020
Lead Sponsor Sanofi
Conditions Neoplasm Malignant
Enrollment 47 participants
Start Date 2020-07-24
Primary Completion 2024-03-02 (estimated)
Study Completion 2026-05-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-14