Clinical Trials in Italy / NCT04950075
Active, not recruiting
Phase 2
Study of INBRX-109 in Conventional Chondrosarcoma
NCT04950075 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Conventional Chondrosarcoma
Investigational drug(s) / intervention(s)
INBRX-109 →Placebo
INBRX-109: Tetravalent DR5 Agonist Antibody
Placebo: Placebo
Study summary
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
Eligibility
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.
Primary outcome measure(s)
- Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo — 3 years
Progression-free survival per RECISTv1.1 will be determined.
Trial sites (68)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Cancer Center | Phoenix | Arizona | |
| Precision NextGen Oncology & Research Center | Beverly Hills | California | |
| University of California, San Francisco (UCSF) | San Francisco | California | |
| Sarcoma Oncology Center | Santa Monica | California | |
| University of Colorado | Denver | Colorado | |
| Yale Cancer Center | New Haven | Connecticut | |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | |
| Moffitt Cancer Center | Tampa | Florida | |
| Northwestern University - Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | |
| Rush Cancer Center | Chicago | Illinois | |
| University of Iowa | Iowa City | Iowa | |
| Johns Hopkins | Baltimore | Maryland | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| University of Michigan | Ann Arbor | Michigan | |
| Mayo Clinic Rochester | Rochester | Minnesota | |
| Washington University School of Medicine - St. Louis | St Louis | Missouri | |
| Nebraska Methodist Hospital | Omaha | Nebraska | |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Columbia University | New York | New York | |
| Duke University | Durham | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| University of Oklahoma - Stephenson Cancer Center | Oklahoma City | Oklahoma | |
| Oregon Health & Science University (OHSU) Knight Cancer Institute | Portland | Oregon | |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| University of Texas Southwestern | Dallas | Texas | |
| MD Anderson Cancer Center | Houston | Texas | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| University of Washington | Seattle | Washington | |
| Royal Adelaide Hospital | Adelaide | Australia | |
| Chris O'Brien Lifehouse | Camperdown | Australia | |
| Princess Alexandra Hospital | Woolloongabba | Australia | |
| Institut Bergonie | Bordeaux | Cedex | |
| 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 |
+ 28 more sites — see the full list on the official registry below.
More Inhibrx Biosciences, Inc trials in Italy
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04950075 on ClinicalTrials.gov ↗ ← All trials in Italy