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NCT04557150CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
225 (actual)
First submitted
17 Sept 2020
Start date
11 Nov 2020
Primary completion date
17 Mar 2026
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04557150
EU CT number
2023-504571-25-00
EudraCT number
2020-002012-46

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 225
  • From 11 Nov 2020 to the primary completion date, 17 Mar 2026
  • 20 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after last dose of study drug.
  • Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for MM treatment within 2 weeks before first forimtamig administration.
  • Prior treatment with systemic immunotherapeutic agents within 2 weeks before first forimtamig administration.
  • Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.
  • Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks, prior to first forimtamig administration. Limited field palliative radiotherapy for bone pain or for soft tissue lesions is allowed.
  • Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to first forimtamig infusion and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication.
  • Prior solid organ transplantation.
  • Active auto-immune disease or flare within 6 months prior to start of study treatment

Lab values

  • Any medical condition or abnormality in clinical laboratory tests that, in the Investigator's or Medical Monitor's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.

Other

  • Inability to comply with protocol-mandated hospitalization and activities restrictions.

Who the study is looking for

  • Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.
  • Dose Escalation Phase and Dose Expansion Phase: Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to or have no other option for standard-of-care treatment according to the Investigator.
  • Life expectancy of at least 12 weeks.
  • Agreement to provide protocol-specific biopsy material.
  • AEs from prior anti-cancer therapy resolved to Grade =\<1.
  • Measurable disease.
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peter MacCallum Cancer Center
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Odense University Hospital
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Odense CDenmarkCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
St James University Hospital
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LeedsUnited KingdomUnknown status
University College London Hospitals NHS Foundation Trust
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LondonUnited KingdomUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyCompleted
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyCompleted
Humanitas Research Hospital
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RozzanoItalyCompleted
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul St. Mary's Hospital
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SeoulSouth KoreaUnknown status
New Zealand Clinical Research - Auckland
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AucklandNew ZealandUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.