Study of INBRX-109 in Conventional Chondrosarcoma

NCT ID: NCT04950075

Last Updated: 2026-01-09

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-23

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Conventional Chondrosarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

INBRX-109 and placebo arms are in parallel. Patients on placebo are allowed to cross-over to open-label INBRX-109 at time of disease progression.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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INBRX-109

IV every three weeks

Group Type EXPERIMENTAL

INBRX-109

Intervention Type DRUG

Tetravalent DR5 Agonist Antibody

Placebo

IV every three weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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INBRX-109

Tetravalent DR5 Agonist Antibody

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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, 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inhibrx Biosciences, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Precision NextGen Oncology & Research Center

Beverly Hills, California, United States

Site Status

University of California, San Francisco (UCSF)

San Francisco, California, United States

Site Status

Sarcoma Oncology Center

Santa Monica, California, United States

Site Status

University of Colorado

Denver, Colorado, United States

Site Status

Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Northwestern University - Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status

Rush Cancer Center

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Johns Hopkins

Baltimore, Maryland, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Washington University School of Medicine - St. Louis

St Louis, Missouri, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Oklahoma - Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

Oregon Health & Science University (OHSU) Knight Cancer Institute

Portland, Oregon, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

University of Texas Southwestern

Dallas, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Royal Adelaide Hospital

Adelaide, , Australia

Site Status

Chris O'Brien Lifehouse

Camperdown, , Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, , Australia

Site Status

Institut Bergonie

Bordeaux, Cedex, France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Leon Berard

Lyon, , France

Site Status

AP-HM - Hôpital de la Timone

Marseille, , France

Site Status

ICM - Institut Regional du Cancer de Montpellier

Montpellier, , France

Site Status

Centre Antoine-Lacassagne

Nice, , France

Site Status

AP-HP Hopital Cochin

Paris, , France

Site Status

Centre Eugene Marquis

Rennes, , France

Site Status

Gustave Roussy

Villejuif, , France

Site Status

Helios Klinikum Berlin-Buch

Berlin, , Germany

Site Status

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Universitätsmedizin Mannheim

Mannheim, , Germany

Site Status

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Site Status

Saint Vincent's University Hospital part of Irish Sarcoma Group

Dublin, , Ireland

Site Status

IRCCS Istituto Ortopedico Rizzoli di Bologna

Bologna, , Italy

Site Status

La Fondazione e l'Istituto di Candiolo

Candiolo, , Italy

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, , Italy

Site Status

Nuovo Ospedale di Prato

Prato, , Italy

Site Status

Policlinico Universitario Campus Biomedico

Roma, , Italy

Site Status

Groningen UMC

Groningen, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau Barcelona

Barcelona, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Clinico Universitario de Santiago

Santiago de Compostela, , Spain

Site Status

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status

University College London Hospital (UCL)

London, , United Kingdom

Site Status

Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Churchill Hospital

Oxford, , United Kingdom

Site Status

Countries

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United States Australia France Germany Ireland Italy Netherlands Spain United Kingdom

Other Identifiers

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Ph2 INBRX-109 SA CS

Identifier Type: -

Identifier Source: org_study_id

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