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TERMINATED
NCT05839626
PHASE1

A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is a first-in-human (FIH) Phase 1/Phase 2 study for evaluating SAR445514 in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light chain amyloidosis (RRLCA). The study will comprise 3 parts: A dose escalation phase (Part 1) in RRMM participants (Part 1a) that will evaluate several doses administered to determine 2 doses that will be tested in the dose optimization part. A dose escalation will also be done in RRLCA participants (Part 1b) but started sequentially after the end of the dose escalation in RRMM participants. This dose escalation will evaluate the 2 doses planned to be used in dose optimization in RRMM, to ensure those doses are safe also for RRLCA participants. A dose optimization phase (Part 2) that will be evaluating 2 doses determined from Part 1 to determine the preliminary recommended Phase 2 dose (pRP2D) and schedule for SAR445514 in RRMM. A dose expansion phase (Part 3) that will evaluate the preliminary efficacy of pRP2D and schedule for SAR445514 in RRMM (Part 3a) and RRLCA (Part 3b). Approximately 111 participants will be enrolled and treated by study intervention and separated as such: Part 1a: Approximately 30 to 40 participants Part 1b: Approximately 6 to 12 participants Part 2: Approximately 30 participants Part 3a: Approximately 15 participants Part 3b: Approximately 14 participants

Official title: First-in-human, Open-label Phase 1/2 Study to Investigate Safety and Efficacy of SAR445514, an NKcell Engager (NKCE) Targeting B-cell Maturation Antigen (BCMA) in Monotherapy in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and in Relapsed/Refractory Light-chain Amyloidosis (RRLCA)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2023-05-15

Completion Date

2025-05-26

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

DRUG

SAR445514

Powder for solution for injection. Sub Cutaneous administration.

Locations (16)

Investigational Site Number : 0360001

Wollongong, New South Wales, Australia

Investigational Site Number : 0360002

Richmond, Victoria, Australia

Institut Jules Bordet_Site Number : 0560002

Anderlecht, Belgium

Het Ziekenhuisnetwerk Antwerpen vzw - ZNA Middelheim_Site Number : 0560001-2

Antwerp, Belgium

Het Ziekenhuisnetwerk Antwerpen vzw - ZNA Cadix_Site Number : 0560001-1

Antwerp, Belgium

Investigational Site Number : 0560001

Antwerp, Belgium

Investigational Site Number : 2030002

Brno, Czechia

Investigational Site Number : 2030001

Ostrava, Czechia

Investigational Site Number : 3480001

Budapest, Hungary

Investigational Site Number : 3800001

Rozzano, Lombardy, Italy

Hospital Universitario Marqués de Valdecilla_Site Number : 7240001

Santander, Cantabria, Spain

Institut Catala d´oncologia - Badalona_Site Number : 7240002

Badalona, Catalonia, Spain

HOSPITAL CLINIC i PROVINCIAL BARCELONA_Site Number : 7240003

Barcelona, Spain

Investigational Site Number : 8260003

Birmingham, United Kingdom

Investigational Site Number : 8260002

London, United Kingdom

Investigational Site Number : 8260001

Manchester, United Kingdom