Treatment of advanced chondrosarcoma with INBRX-109
A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
This study is testing a new treatment called INBRX-109 to see if it can help people with advanced chondrosarcoma that can't be surgically removed or has spread to other parts of the body.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 201 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Inhibrx Biosciences, Inc Industry-sponsored |
| Locations | 58 sites (Phoenix, Arizona and 57 other locations) |
| Trial ID | NCT04950075 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial evaluates the efficacy of INBRX-109, a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5), in patients with unresectable or metastatic conventional chondrosarcoma. The study is randomized, blinded, and placebo-controlled, ensuring that the results are robust and reliable. Participants will be monitored for measurable disease progression and overall response to treatment over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates include individuals with unresectable or metastatic conventional chondrosarcoma who have measurable disease and meet specific health criteria.
Not a fit: Patients with non-conventional chondrosarcoma or those who have previously been treated with DR5 agonists may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced chondrosarcoma, potentially improving survival rates and quality of life.
How similar studies have performed: Other studies targeting DR5 have shown promise, suggesting that this approach may be effective, although this specific application in chondrosarcoma is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona and 57 other locations
- Mayo Clinic Cancer Center — Phoenix, Arizona, United States (Recruiting)
- Precision NextGen Oncology & Research Center — Beverly Hills, California, United States (Recruiting)
- University of California, San Francisco (UCSF) — San Francisco, California, United States (Recruiting)
- Sarcoma Oncology Center — Santa Monica, California, United States (Recruiting)
- University of Colorado — Denver, Colorado, United States (Recruiting)
- Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States (Recruiting)
- Rush Cancer Center — Chicago, Illinois, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Washington University School of Medicine - St. Louis — Saint Louis, Missouri, United States (Recruiting)
- Nebraska Methodist Hospital — Omaha, Nebraska, United States (Recruiting)
- Norris Cotton Cancer Center — Lebanon, New Hampshire, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Columbia University — New York, New York, United States (Active_not_recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- University of Oklahoma - Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Oregon Health & Science University (OHSU) Knight Cancer Institute — Portland, Oregon, United States (Recruiting)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- Royal Adelaide Hospital — Adelaide, Australia (Recruiting)
- Chris O'Brien Lifehouse — Camperdown, Australia (Recruiting)
- Princess Alexandra Hospital — Woolloongabba, Australia (Recruiting)
- Institut Bergonie — Bordeaux, Cedex, France (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- Centre Leon Berard — Lyon, France (Recruiting)
- AP-HM - Hôpital de la Timone — Marseille, France (Recruiting)
- Gustave Roussy — Villejuif, France (Recruiting)
- Helios Klinikum Berlin-Buch — Berlin, Germany (Recruiting)
- Universitätsmedizin Mannheim — Mannheim, Germany (Recruiting)
- Saint Vincent's University Hospital part of Irish Sarcoma Group — Dublin, Ireland (Recruiting)
- IRCCS Istituto Ortopedico Rizzoli di Bologna — Bologna, Italy (Recruiting)
- La Fondazione e l'Istituto di Candiolo — Candiolo, Italy (Recruiting)
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milano, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone — Palermo, Italy (Recruiting)
- Nuovo Ospedale di Prato — Prato, Italy (Recruiting)
- Policlinico Universitario Campus Biomedico — Roma, Italy (Recruiting)
- Groningen UMC — Groningen, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (Recruiting)
+8 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Study Director, -Inhibrx
- Email: clinicaltrials@inhibrx.com
- Phone: 858-500-7833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.