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NCT05862012PHASE1Recruiting

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Ichnos Sciences SA

Start Date

11/1/2023

Completion Date

7/1/2027

Summary

This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).

Detailed Description

The study enrolls participants with R/R MM that have been treated with immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in MM. The study is conducted in two parts: Part 1 dose escalation and Part 2 dose expansion. Dose escalation continued until the maximum planned dose was reached. Dose expansion cohorts were initiated to further confirm safety and optimal biologically active dose. Participants receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma 2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less 3. Must have adequate hematologic, hepatic, renal, and cardiac functions Exclusion Criteria: 1. Active malignant central nervous system involvement 2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1 3. History of autoimmune disease requiring systemic immunosuppressive therapy 4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study. 5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.

Interventions

DRUG

ISB 2001

DRUG

ISB 2001

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Conditions

Relapsed/Refractory Multiple Myeloma

Locations

Standford Cancer Institute

Palo Alto, California 94304

United States

Sylvester Cancer Center

Miami, Florida 33136

United States

Winship Cancer Institute

Atlanta, Georgia 30322

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

University of North Carolina

Chapel Hill, North Carolina 27599

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

Virginia Commonwealth University (VCU)

Richmond, Virginia 23298

United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Concord Hospital

Concord, New South Wales 2139

Australia

Pindara Private Hospital

Benowa, Queensland 4217

Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria 3065

Australia

Peter MacCallum Cancer Center

Melbourne, Victoria 3000

Australia

Linear Clinical Research

Nedlands, Western Australia 6009

Australia

CHRU Lille

Lille, Hauts-de-France 59800

France

CHU Poiters - Hospital la Miletrie

Poitiers, New Aquitaine 86021

France

CHU de Nantes - Hotel Dieu

Nantes, Pays de la Loire Region 44093

France

Groupe Hospitalier Pitie-Salpetriere

Paris, Île-de-France Region 75013

France

Apollo Hospital International Limited

Gandhinagar, Gujarat 382428

India

Health Care Global Enterprises Ltd.

Bangalore, Karnataka 560027

India

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashta 411004

India

Apollo Cancer Centers

Hyderabad, Telangana 500033

India

HCG Hospital

Bangalore,

India

ASST Spedali Civili di Brescia

Brescia, Lombardy 25123

Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, Lombardy 20122

Italy

Oslo University Hospital

Oslo, Oslo 0372

Norway

Instituto de Investigacion Biomedica de Salamanca (IBSAL)

Salamanca, Castile de Leon 37007

Spain

Institut Catala de Oncologia (ICO)

Badalona, Catalonia 08916

Spain

Hospital Clinic de Barcelona

Barcelona, Catalonia 08036

Spain

Centro Integral Oncologici Clara Campal

Madrid, Madrid 28050

Spain

Clinica Universidad de Nevarra

Pamplona, Navarre 31008

Spain