Study of INBRX-109 in Conventional Chondrosarcoma
About the study
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
- Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
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.
Other exclusion criteria per protocol.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Conventional Chondrosarcoma
Age (in years)
18 - 85
Phase
Phase 2
Participants needed
201
Est. Completion Date
Jun 30, 2024
Treatment type
Interventional
Sponsor
Inhibrx, Inc.
ClinicalTrials.gov identifier
NCT04950075
Study number
Ph2 INBRX-109 SA CS
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