Study of INBRX-109 in Conventional Chondrosarcoma

Last updated: January 9, 2025
Sponsor: Inhibrx Biosciences, Inc
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer/tumors

Bone Neoplasm

Soft Tissue Sarcoma

Treatment

Placebo

INBRX-109

Clinical Study ID

NCT04950075
Ph2 INBRX-109 SA CS
  • Ages 18-85
  • All Genders

Study Summary

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.

  2. Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previouslyirradiated (or other locally treated) area will be considered measurable, providedthere has been clear imaging-based progression of the lesions since the time oftreatment.

  3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior toscreening for this study.

  4. Adequate hematologic, coagulation, hepatic and renal function as defined perprotocol.

  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

Exclusion Criteria:

  1. Any prior exposure to DR5 agonists.

  2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.

  3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletalmyxoid, myxoid, and dedifferentiated chondrosarcoma.

  4. Prior or concurrent malignancies. Exception: Patients with a prior or concurrentmalignancy whose natural history or treatment does not have the potential tointerfere with the safety or efficacy assessments.

  5. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptableas long as adequate hepatic function as defined in the inclusion/exclusion criteriais confirmed.

  6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.

  7. Other exclusion criteria per protocol.

Study Design

Total Participants: 201
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 23, 2021
Estimated Completion Date:
December 31, 2026

Study Description

This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, 5000
    Australia

    Active - Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, 2050
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba,
    Australia

    Active - Recruiting

  • Institut Bergonie

    Bordeaux, Cedex 33076
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille, 59020
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69373
    France

    Active - Recruiting

  • AP-HM - Hôpital de la Timone

    Marseille, 13005
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Helios Klinikum Berlin-Buch

    Berlin, 13125
    Germany

    Active - Recruiting

  • Universitätsmedizin Mannheim

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Saint Vincent's University Hospital part of Irish Sarcoma Group

    Dublin, D04 T6F4
    Ireland

    Active - Recruiting

  • IRCCS Istituto Ortopedico Rizzoli di Bologna

    Bologna, 40136
    Italy

    Active - Recruiting

  • Fondazione del Piemonte per I'Oncologia - Istituto di Candiolo IRCC

    Candiolo, 10060
    Italy

    Active - Recruiting

  • La Fondazione e l'Istituto di Candiolo

    Candiolo, 10060
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127
    Italy

    Active - Recruiting

  • Nuovo Ospedale di Prato

    Prato, 59100
    Italy

    Active - Recruiting

  • Policlinico Universitario Campus Biomedico

    Roma, 00128
    Italy

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Groningen UMC

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden, 2333 ZA
    Netherlands

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau Barcelona

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Ankara City Hospital

    Ankara, 06800
    Turkey

    Site Not Available

  • Uludag University Medical Faculty

    Bursa, 16059
    Turkey

    Site Not Available

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098
    Turkey

    Site Not Available

  • Erciyes University Faculty of Medicine

    Melikgazi, 38030
    Turkey

    Site Not Available

  • Royal Marsden NHS Foundation Trust

    London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • University College London (UCL) - Medical School

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • University College London Hospital (UCL)

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Churchill Hospital

    Oxford, OX3 7LJ
    United Kingdom

    Active - Recruiting

  • Mayo Clinic Cancer Center

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Precision NextGen Oncology & Research Center

    Beverly Hills, California 90212
    United States

    Active - Recruiting

  • University of California, San Francisco (UCSF)

    San Francisco, California 94110
    United States

    Active - Recruiting

  • Sarcoma Oncology Center

    Santa Monica, California 90403
    United States

    Active - Recruiting

  • University of Colorado

    Denver, Colorado 80220
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Northwestern University - Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Rush Cancer Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Washington University School of Medicine - St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire 03766
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Oklahoma State University (OSU) - Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • University of Oklahoma - Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Oregon Health & Science University (OHSU) Knight Cancer Institute

    Portland, Oregon 97201
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19106
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Washington University - Seattle

    Seattle, Washington 98109
    United States

    Active - Recruiting

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