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Study of INBRX-109 in Conventional Chondrosarcoma
Trial Status: closed to accrual
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or
metastatic conventional chondrosarcoma patients.
Inclusion Criteria
Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
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.
Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Estimated life expectancy of at least 12 weeks.
Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion Criteria
Any prior exposure to DR5 agonists.
Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
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.
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.
Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
Other exclusion criteria per protocol.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04950075.
Locations matching your search criteria
United States
Illinois
Chicago
Northwestern University
Status: Active
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Temporarily closed to accrual
Name Not Available
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available
Oregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
Tennessee
Nashville
Vanderbilt University/Ingram Cancer Center
Status: Active
Name Not Available
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).