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NCT04401020 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Neoplasm Malignant, sponsored by Sanofi.

Active
Registry status
Phase 1
Development phase
47
Enrollment target
16
Study locations

NCT04401020 is a Phase 1 study of Neoplasm Malignant that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 47 participants, below the 284-participant average among 7 other Neoplasm Malignant trials with a reported enrollment target (83% lower). The trial reports 16 study locations across 9 states.

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The verdict

NCT04401020, a Phase 1 study of Neoplasm Malignant, is active but no longer recruiting, sponsored by Sanofi.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
47 participants
Enrollment target
16
Study locations

Study 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

Conditions Studied

Neoplasm Malignant

Interventions

  • DRUG SAR442257

Study Locations (16)

Other

  • Investigational Site Number : 2030003 - Brno
  • Investigational Site Number : 2030001 - Ostrava - Poruba
  • Investigational Site Number : 2030002 - Prague
  • Investigational Site Number : 5780001 - Oslo
  • Investigational Site Number : 5780101 - Oslo
  • Investigational Site Number : 7240007 - Madrid
  • Investigational Site Number : 7240004 - Valencia

Seoul-teukbyeolsi

  • Investigational Site Number : 4100001 - Seoul
  • Investigational Site Number : 4100002 - Seoul

California

  • City of Hope Site Number : 8400001 - Duarte

Florida

  • University of Miami - Sylvester Comprehensive Cancer Center Site Number : 8400005 - Miami

Minnesota

  • Mayo Clinic of Rochester Site Number : 8400003 - Rochester

Cantabria

  • Investigational Site Number : 7240005 - Santander

Catalunya [Cataluña]

  • Investigational Site Number : 7240003 - Badalona

Madrid, Comunidad de

  • Investigational Site Number : 7240006 - Madrid

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2020-07-24
Est. Completion 2026-03-17
Phase Phase 1

Sponsor

Sanofi

713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04401020

The ClinicalTrials.gov registry entry for NCT04401020 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 7 other Neoplasm Malignant trials with a reported enrollment target (83% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neoplasm Malignant appearing as the primary indexed condition, and to 1 intervention - of which SAR442257 is the first listed.

NCT04401020 reports 16 study locations spanning 9 distinct geographic areas - top geographies include Other, Seoul-teukbyeolsi, California.

Frequently Asked Questions

What is clinical trial NCT04401020 about?

NCT04401020 is a clinical study titled "First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL". 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 Objec...

What is the current status of trial NCT04401020?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2020-07-24. Estimated completion is 2026-03-17.

What conditions does trial NCT04401020 study?

This clinical trial studies the following conditions: Neoplasm Malignant.

What interventions are being tested in trial NCT04401020?

The interventions under investigation include: SAR442257 (DRUG).

Who is sponsoring clinical trial NCT04401020?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04401020 being conducted?

This trial has 16 study locations across California, Florida, Minnesota, Seoul-teukbyeolsi, Cantabria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.