Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
206 participants
INTERVENTIONAL
2021-09-23
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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INBRX-109
IV every three weeks
INBRX-109
Tetravalent DR5 Agonist Antibody
Placebo
IV every three weeks
Placebo
Placebo
Interventions
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INBRX-109
Tetravalent DR5 Agonist Antibody
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment.
3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
6. Estimated life expectancy of at least 12 weeks.
7. Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion Criteria
2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
4. Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments.
6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
18 Years
85 Years
ALL
No
Sponsors
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Inhibrx Biosciences, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Lead
Role: STUDY_DIRECTOR
Inhibrx Biosciences, Inc
Locations
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Mayo Clinic Cancer Center
Phoenix, Arizona, United States
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States
University of California, San Francisco (UCSF)
San Francisco, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
University of Colorado
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States
Rush Cancer Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School of Medicine - St. Louis
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University (OHSU) Knight Cancer Institute
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
University of Washington
Seattle, Washington, United States
Royal Adelaide Hospital
Adelaide, , Australia
Chris O'Brien Lifehouse
Camperdown, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Institut Bergonie
Bordeaux, Cedex, France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
AP-HM - Hôpital de la Timone
Marseille, , France
ICM - Institut Regional du Cancer de Montpellier
Montpellier, , France
Centre Antoine-Lacassagne
Nice, , France
AP-HP Hopital Cochin
Paris, , France
Centre Eugene Marquis
Rennes, , France
Gustave Roussy
Villejuif, , France
Helios Klinikum Berlin-Buch
Berlin, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitätsmedizin Mannheim
Mannheim, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Saint Vincent's University Hospital part of Irish Sarcoma Group
Dublin, , Ireland
IRCCS Istituto Ortopedico Rizzoli di Bologna
Bologna, , Italy
La Fondazione e l'Istituto di Candiolo
Candiolo, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Nuovo Ospedale di Prato
Prato, , Italy
Policlinico Universitario Campus Biomedico
Roma, , Italy
Groningen UMC
Groningen, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Fundación Jiménez Díaz
Madrid, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
University College London Hospital (UCL)
London, , United Kingdom
Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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Ph2 INBRX-109 SA CS
Identifier Type: -
Identifier Source: org_study_id
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