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

NCT04401020 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-05-08

No results posted yet for this 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

  • Neoplasm Malignant

Interventions

DRUG

SAR442257

Pharmaceutical form: Sterile powder for reconstitution Route of administration: Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2024-03-02
Completion
2026-05-11
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Norway
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04401020 on ClinicalTrials.gov