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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 the 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04557150
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, Denmark, France, Italy, Korea, Republic of, New Zealand, Spain, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

Experimental: Part I: Dose Escalation

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

Experimental: 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.

Interventions

Drug: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Peter MacCallum Cancer Center, North Melbourne, Victoria, Australia

Status

Active, not recruiting

Address

Peter MacCallum Cancer Center

North Melbourne, Victoria, 3051

UZ Gent, Gent, Belgium

Status

Recruiting

Address

UZ Gent

Gent, , 9000

København Ø, Denmark

Status

Recruiting

Address

Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

København Ø, , 2100

Odense C, Denmark

Status

Recruiting

Address

Odense Universitetshospital; Hæmatologisk Afdeling

Odense C, , 5000

Lille, France

Status

Recruiting

Address

CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang

Lille, , 59037

Nantes, France

Status

Recruiting

Address

CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique

Nantes, , 44093

Pessac, France

Status

Active, not recruiting

Address

Hopital De Haut Leveque; Hematologie Clinique

Pessac, , 33604

Napoli, Campania, Italy

Status

Recruiting

Address

IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica

Napoli, Campania, 80131

Bologna, Emilia-Romagna, Italy

Status

Recruiting

Address

Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"

Bologna, Emilia-Romagna, 40138

Milano, Lombardia, Italy

Status

Recruiting

Address

Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia

Milano, Lombardia, 20133

Rozzano, Lombardia, Italy

Status

Active, not recruiting

Address

Instituto Clinico Humanitas; Med Onc & Hemat

Rozzano, Lombardia, 20089

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Asan Medical Center, Seoul, Korea, Republic of

Status

Withdrawn

Address

Asan Medical Center

Seoul, , 05505

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 06351

Seoul St Mary's Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul St Mary's Hospital

Seoul, , 06591

New Zealand Clinical Research - Auckland, Auckland, New Zealand

Status

Recruiting

Address

New Zealand Clinical Research - Auckland

Auckland, , 1010

Santander, Cantabria, Spain

Status

Active, not recruiting

Address

Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

Santander, Cantabria, 39008

Pamplona, Navarra, Spain

Status

Recruiting

Address

Clinica Universitaria de Navarra; Servicio de Hematologia

Pamplona, Navarra, 31008

Salamanca, Spain

Status

Recruiting

Address

Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

Salamanca, , 37007

Leeds, United Kingdom

Status

Recruiting

Address

St James University Hospital; Institute of Oncology

Leeds, , LS9 7TF

London, United Kingdom

Status

Recruiting

Address

University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

London, , W1T 7HA