A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
NCT ID: NCT04557150
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
225 participants
INTERVENTIONAL
2020-11-11
2026-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part I: Dose Escalation
Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.
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.
Part II: Dose Expansion
Dose Expansion cohorts with IV and/or SC administration, respectively, will be initiated at the Recommended Phase 2 Doses (RP2Ds) determined in Part I: Dose Escalation phase.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Napoli, 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
Countries
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References
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Eckmann J, Fauti T, Biehl M, Zabaleta A, Blanco L, Lelios I, Gottwald S, Rae R, Lechner S, Bayer C, Dekempe Q, Osl F, Carrie N, Kassem S, Lorenz S, Christopeit T, Carpy A, Bujotzek A, Broske AM, Dekhtiarenko I, Attig J, Kunz L, Cremasco F, Adelfio R, Fertig G, Dengl S, Gassner C, Bormann F, Kirstenpfad C, Kraft T, Diggelmann S, Knobloch M, Hage C, Feddersen R, Heidkamp G, Poschinger T, Mayoux M, Bernasconi L, Prosper F, Dumontet C, Martinet L, Leclair S, Xu W, Paiva B, Klein C, Umana P. Forimtamig, a novel GPRC5D-targeting T-cell bispecific antibody with a 2+1 format, for the treatment of multiple myeloma. Blood. 2025 Jan 9;145(2):202-219. doi: 10.1182/blood.2024025987.
Other Identifiers
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BP42233
Identifier Type: -
Identifier Source: org_study_id
2020-002012-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504571-25-00
Identifier Type: CTIS
Identifier Source: secondary_id