A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 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. RO7425781 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 RO7425781 (Part 1) and a randomized dose expansion of RO7425781 (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: 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.
  • - Dose Expansion Phase: Participants with r/r MM who have received at least three prior treatments and are refractory to an IMiD, a PI, and a CD38-targeted therapy.
  • - 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 within 2 weeks before first RO7425781 administration.
  • - Prior treatment with systemic immunotherapeutic agents within 2 weeks before first RO7425781 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 except for alkylating agents (e.g., melphalan) within 28 days, prior to first RO7425781 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 RO7425781 administration and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication.
  • - Prior solid organ transplantation.
  • - 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, Spain, United Kingdom, United States
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 RO7425781 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 will be initiated at the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) determined from Part I: Dose Escalation.

Interventions

Drug: - RO7425781

RO7425781 will be administered via IV/SC administration. The MTD/RP2D determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. RO7425781 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.

City of Hope, Duarte, California

Status

Not yet recruiting

Address

City of Hope

Duarte, California, 91010

Houston, Texas

Status

Not yet recruiting

Address

MD Anderson Cancer Center Department of Lymphoma & Myeloma

Houston, Texas, 77030

International Sites

Peter MacCallum Cancer Center, East Melbourne, Victoria, Australia

Status

Recruiting

Address

Peter MacCallum Cancer Center

East Melbourne, Victoria, 3002

UZ Gent, Gent, Belgium

Status

Recruiting

Address

UZ Gent

Gent, , 9000

Rigshospitalet; Hæmatologisk Klinik, København Ø, Denmark

Status

Recruiting

Address

Rigshospitalet; Hæmatologisk Klinik

København Ø, , 2100

Lille, France

Status

Recruiting

Address

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

Lille, , 59037

Nantes, France

Status

Not yet recruiting

Address

CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique

Nantes, , 44093

Pessac, France

Status

Not yet recruiting

Address

Hopital De Haut Leveque; Hematologie Clinique

Pessac, , 33604

Napoli, Campania, Italy

Status

Not yet recruiting

Address

IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica

Napoli, Campania, 80131

Milano, Lombardia, Italy

Status

Not yet recruiting

Address

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

Milano, Lombardia, 20133

Rozzano, Lombardia, Italy

Status

Recruiting

Address

Instituto Clinico Humanitas; Med Onc & Hemat

Rozzano, Lombardia, 20089

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 05505

Santander, Cantabria, Spain

Status

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

Not yet recruiting

Address

St James University Hospital; Institute of Oncology

Leeds, , LS9 7TF

London, United Kingdom

Status

Not yet recruiting

Address

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

London, , W1T 7HA