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

NCT04557150 | Completed Phase 1 FDA Drug

• 3 other identifiers: BP422332020-002012-462023-504571-25-00
• Study Type: interventional
• Target: 225
• Locations: 9 countries
• Sites: 20

Brief 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).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Adverse Events (AEs)

  Up to 104 weeks

• Percentage of Participants with Dose Limiting Toxicities (DLTs)

  Cycle 1 Day 1 up to Cycle 1 Day 35

Secondary Outcomes (12)

• Objective Response Rate (ORR)

  Up to 104 weeks

• Duration of Response (DOR)

  Up to 104 weeks

• Progression-Free Survival (PFS)

  Up to 104 weeks

• Overall Survival (OS)

  Up to 104 weeks

• Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig

  Up to 104 weeks

Study Arms (2)

Part I: Dose Escalation

EXPERIMENTAL

Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.

Drug: Forimtamig

Part II: Dose Expansion

EXPERIMENTAL

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.

Drug: Forimtamig

Interventions

Forimtamig DRUG

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.

Also known as: RO7425781

Part I: Dose Escalation; Part II: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (20)

Peter MacCallum Cancer Center

Melbourne, Victoria, 3000, Australia

Location

UZ Gent

Ghent, 9000, Belgium

Location

Rigshospitalet

København Ø, 2100, Denmark

Location

Odense Universitetshospital

Odense C, 5000, Denmark

Location

CHRU Lille - Hôpital Claude Huriez

Lille, 59037, France

Location

CHU NANTES - Hôtel Dieu

Nantes, 44093, France

Location

Hopital De Haut Leveque

Pessac, 33604, France

Location

IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica

Naples, Campania, 80131, Italy

Location

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

Fond. IRCCS Istituto Nazionale Tumori

Milan, Lombardy, 20133, Italy

Location

Instituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

Location

New Zealand Clinical Research - Auckland

Auckland, 1010, New Zealand

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St Mary's Hospital

Seoul, 06591, South Korea

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

St James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, W1T 7HA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39476124 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 21, 2020
• Study Start: November 11, 2020
• Primary Completion: March 17, 2026
• Study Completion: March 17, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1); FR (3); IT (4); AU (1); ES (3); GB (2); KR (3); BE (1); DK (2)