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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
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
Conditions
Interventions
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