Overview
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).
Principal investigator
Eligibility criteria
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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