Study on INBRX-109 for Treating Conventional Chondrosarcoma
Sponsor: Inhibrx Biosciences, Inc
ClinicalTrials ID:NCT04950075
This clinical trial is testing a new drug, INBRX-109, to see if it can help treat patients with conventional chondrosarcoma that cannot be surgically removed or has spread to other parts of the body.
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Program Overview
The purpose of this study is to evaluate the effectiveness and safety of a new treatment called INBRX-109 for patients with conventional chondrosarcoma that is either inoperable or has metastasized. INBRX-109 is a specially designed antibody that targets a specific receptor on cancer cells to help fight the disease.
Description
This study is a Phase 2 trial, meaning it is focused on assessing how well the new treatment works and its safety in patients. Participants will be randomly assigned to receive either the INBRX-109 treatment or a placebo, which is a substance with no active drug, to compare the effects. The study is 'blinded,' meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results. INBRX-109 is a humanized antibody that targets a receptor known as DR5 on cancer cells, which may help in controlling the growth of the tumor.
Eligibility Criteria
Inclusion Criteria
- Have conventional chondrosarcoma that cannot be surgically removed or has spread to other areas.
- Have tumors that can be measured using specific medical criteria.
- Show signs of disease progression based on recent imaging tests.
- Have adequate blood, liver, and kidney function as determined by medical tests.
- Be in good general health with a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a life expectancy of at least 12 weeks.
- Provide a previous or new tissue sample from the cancer for analysis.
Exclusion Criteria
- Have previously been treated with drugs targeting the DR5 receptor.
- Have allergies to INBRX-109 or similar antibodies.
- Have a type of chondrosarcoma other than conventional, such as clear-cell or mesenchymal.
- Have other cancers that could interfere with the study's assessments, unless they are not expected to affect the study.
- Have chronic liver diseases, except for fatty liver disease if liver function is adequate.
- Have a history of multiple sclerosis or similar disorders.
- Other criteria as specified in the study protocol.
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