Study of INBRX-109 in Conventional Chondrosarcoma
Trial Status: active
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.
- Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
- 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.
Additional locations may be listed on ClinicalTrials.gov for NCT04950075.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not AvailableIllinois
Chicago
Northwestern University
Status: Active
Name Not AvailableIowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not AvailableMaryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not AvailableNew York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableNorth Carolina
Durham
Duke University Medical Center
Status: Temporarily closed to accrual
Name Not AvailableOklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not AvailableOregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not AvailablePennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not AvailableTennessee
Nashville
Vanderbilt University/Ingram Cancer Center
Status: Active
Name Not AvailableThis 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).
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationInhibrx Biosciences, Inc
- Primary IDPh2 INBRX-109 SA CS
- Secondary IDsNCI-2021-10034
- ClinicalTrials.gov IDNCT04950075