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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: Active Phase 1 study of Neoplasm Malignant, sponsored by Sanofi.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

MTD: defined as the highest dose level (DL) with highest probability of Investigational Medicinal Product (IMP)-related dose limiting toxicity (DLT) rate within the target range (16 to 33%) among dose levels with less than 0.25 probability of DLT rate above target (\>33%)

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
Sanofi

713 total trials

What the registry record for NCT04401020 still lists

NCT04401020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 284-participant average among 7 other Neoplasm Malignant trials with a reported enrollment target (83% lower).

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 lists 16 locations in 9 states (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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Related registry views

Source: ClinicalTrials.gov NCT04401020, the US trial registry maintained by the National Library of Medicine. NCT04401020 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.