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New hope for Hard-to-Treat myeloma: first human trial of forimtamig begins

NCT ID NCT04557150

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a new drug called forimtamig in 225 people with multiple myeloma that had returned or stopped responding to standard treatments. The main goals were to check safety and find the right dose. Participants received the drug by IV or injection, and researchers monitored side effects and how the drug moved through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Forimtamig (RO7425781)
What this could lead to
If successful, this could lead to a new treatment option for people with multiple myeloma who have run out of standard therapies.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it is not yet proven to work. Side effects and limited effectiveness are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

225 people

The number who actually took part.

Started

Nov 2020

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * Inability to comply with protocol-mandated hospitalization and activities restrictions. * 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 * 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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • CHRU Lille - Hôpital Claude Huriez

    Lille, 59037, France

  • CHU NANTES - Hôtel Dieu

    Nantes, 44093, France

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Fond. IRCCS Istituto Nazionale Tumori

    Milan, Lombardy, 20133, Italy

  • Hopital De Haut Leveque

    Pessac, 33604, France

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica

    Naples, Campania, 80131, Italy

  • Instituto Clinico Humanitas

    Rozzano, Lombardy, 20089, Italy

  • New Zealand Clinical Research - Auckland

    Auckland, 1010, New Zealand

  • Odense Universitetshospital

    Odense C, 5000, Denmark

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000, Australia

  • Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138, Italy

  • Rigshospitalet

    København Ø, 2100, Denmark

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Seoul St Mary's Hospital

    Seoul, 06591, South Korea

  • St James University Hospital

    Leeds, LS9 7TF, United Kingdom

  • UZ Gent

    Ghent, 9000, Belgium

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA, United Kingdom

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