Study of INBRX-109 in Conventional Chondrosarcoma

Launched by INHIBRX BIOSCIENCES, INC · Jun 30, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called INBRX-109 for patients with a type of cancer called conventional chondrosarcoma, which is either inoperable (meaning it can't be surgically removed) or has spread to other parts of the body. The study is in Phase 2, meaning it's testing the treatment's effectiveness and safety in a larger group of patients. If you're between the ages of 65 and 104 and have measurable disease progression in the past six months, you may be eligible to participate. Other requirements include having a good overall health status and enough cancer tissue available for testing.

Participants in this trial will receive either the active treatment (INBRX-109) or a placebo (a treatment that looks like the real thing but has no active ingredients) in a randomized and blinded manner, meaning neither the patients nor the doctors will know which treatment they receive. This helps ensure unbiased results. The trial is currently recruiting participants, and it aims to gather important information about how well this new treatment works and what side effects it may cause. If you're considering joining, be sure to ask your doctor any questions you have about the study and what it might mean for your treatment options.

Gender

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Eligibility criteria

• 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.