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ACTIVE NOT RECRUITING
NCT04557150
PHASE1

A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. Forimtamig will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of forimtamig (Part 1) and a randomized dose expansion of forimtamig (Part 2).

Official title: An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig (RO7425781) in Participants With Relapsed or Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

225

Start Date

2020-11-11

Completion Date

2026-03-30

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

Forimtamig

Forimtamig will be administered via IV/SC administration. The RP2Ds determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. Forimtamig will be administered as per the dosing schedule defined in Part I.

Locations (20)

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia

UZ Gent

Ghent, Belgium

Rigshospitalet

København Ø, Denmark

Odense Universitetshospital

Odense C, Denmark

CHRU Lille - Hôpital Claude Huriez

Lille, France

CHU NANTES - Hôtel Dieu

Nantes, France

Hopital De Haut Leveque

Pessac, France

IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica

Naples, Campania, Italy

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, Italy

Fond. IRCCS Istituto Nazionale Tumori

Milan, Lombardy, Italy

Instituto Clinico Humanitas

Rozzano, Lombardy, Italy

New Zealand Clinical Research - Auckland

Auckland, New Zealand

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul St Mary's Hospital

Seoul, South Korea

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

St James University Hospital

Leeds, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom