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