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New antibody drug shows promise for rare bone cancer

NCT ID NCT04950075

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This phase 2 trial tests a drug called INBRX-109 in people with a rare bone cancer (conventional chondrosarcoma) that cannot be removed by surgery or has spread. The drug is a lab-made antibody designed to kill cancer cells. About 206 participants will receive either INBRX-109 or a placebo to see if the drug slows cancer growth and improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INBRX-109 (a lab-made antibody that targets a protein on cancer cells to trigger cell death)
What this could lead to
If it works, this could provide a new treatment option to slow tumor growth and extend life for people with advanced chondrosarcoma, a rare bone cancer with few effective therapies.
What could go wrong
This is a mid-stage trial with only 206 participants, so results may not confirm benefit. The drug may cause side effects like fatigue or liver issues, and there is no guarantee it will outperform placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

206 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 5. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed. 6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders. 7. Other exclusion criteria per protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AP-HM - Hôpital de la Timone

    Marseille, 13005, France

  • AP-HP Hopital Cochin

    Paris, France

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127, Italy

  • Centre Antoine-Lacassagne

    Nice, France

  • Centre Eugene Marquis

    Rennes, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Chris O'Brien Lifehouse

    Camperdown, 2050, Australia

  • Churchill Hospital

    Oxford, OX3 7LJ, United Kingdom

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02114, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Groningen UMC

    Groningen, 9713 GZ, Netherlands

  • Gustave Roussy

    Villejuif, 94805, France

  • Helios Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Spain

  • Hospital Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hospital de la Santa Creu i Sant Pau Barcelona

    Barcelona, 08041, Spain

  • ICM - Institut Regional du Cancer de Montpellier

    Montpellier, France

  • IRCCS Istituto Ortopedico Rizzoli di Bologna

    Bologna, 40136, Italy

  • Institut Bergonie

    Bordeaux, Cedex, 33076, France

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • La Fondazione e l'Istituto di Candiolo

    Candiolo, 10060, Italy

  • Leiden University Medical Center

    Leiden, 2333 ZA, Netherlands

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Cancer Center

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 99505, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03766, United States

  • Northwestern University - Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611, United States

  • Nuovo Ospedale di Prato

    Prato, 59100, Italy

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

    Portland, Oregon, 97201, United States

  • Policlinico Universitario Campus Biomedico

    Roma, 00128, Italy

  • Precision NextGen Oncology & Research Center

    Beverly Hills, California, 90212, United States

  • Princess Alexandra Hospital

    Woolloongabba, Australia

  • Royal Adelaide Hospital

    Adelaide, 5000, Australia

  • Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • Rush Cancer Center

    Chicago, Illinois, 60612, United States

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

    Dublin, D04 T6F4, Ireland

  • Sarcoma Oncology Center

    Santa Monica, California, 90403, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Universitaetsklinikum Heidelberg

    Heidelberg, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, Germany

  • University College London Hospital (UCL)

    London, NW1 2PG, United Kingdom

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94110, United States

  • University of Colorado

    Denver, Colorado, 80220, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Oklahoma - Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • University of Washington

    Seattle, Washington, 98109, United States

  • Universitätsmedizin Mannheim

    Mannheim, 68167, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Washington University School of Medicine - St. Louis

    St Louis, Missouri, 63110, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06519, United States