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ACTIVE NOT RECRUITING
NCT04401020
PHASE1

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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

Official title: An Open-label, First-in-human, Single Agent, Dose Escalation Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442257 in Patients With Relapsed and Refractory Multiple Myeloma and Relapsed and Refractory Non-Hodgkin Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

47

Start Date

2020-07-24

Completion Date

2026-03-17

Last Updated

2025-03-21

Healthy Volunteers

No

Interventions

DRUG

SAR442257

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

Locations (16)

City of Hope Site Number : 8400001

Duarte, California, United States

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

Miami, Florida, United States

Mayo Clinic of Rochester Site Number : 8400003

Rochester, Minnesota, United States

Investigational Site Number : 2030003

Brno, Czechia

Investigational Site Number : 2030001

Ostrava - Poruba, Czechia

Investigational Site Number : 2030002

Prague, Czechia

Investigational Site Number : 5780001

Oslo, Norway

Investigational Site Number : 5780101

Oslo, Norway

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240005

Santander, Cantabria, Spain

Investigational Site Number : 7240003

Badalona, Catalunya [Cataluña], Spain

Investigational Site Number : 7240006

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240001

Pamplona, Navarre, Spain

Investigational Site Number : 7240007

Madrid, Spain

Investigational Site Number : 7240004

Valencia, Spain