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ACTIVE NOT RECRUITING Phase 1

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

NCT04401020 · View on ClinicalTrials.gov ↗

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

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

275 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04401020 reports 16 study locations spanning 9 distinct geographic areas — top geographies include Other, Seoul-teukbyeolsi, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04401020?

The interventions under investigation include: SAR442257 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04401020?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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