Study on INBRX-106 Alone and with Pembrolizumab (Keytruda®) for Advanced Solid Tumors
Sponsor: Inhibrx Biosciences, Inc
Sponsor score: 0
Inactive
ClinicalTrials ID:NCT04198766
This clinical trial is testing the safety and best dose of a new drug, INBRX-106, alone and in combination with pembrolizumab (Keytruda®), for adults with advanced solid tumors that cannot be surgically removed.
Patient Parameters
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Program Overview
This study is in two phases and aims to find out how safe INBRX-106 is and what dose works best when used alone or with pembrolizumab (Keytruda®) in treating advanced solid tumors. The trial is open-label, meaning both the researchers and participants know what treatment is being given. It is non-randomized, so all participants receive the treatment being studied.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Have advanced solid tumors that cannot be surgically removed and have worsened despite standard treatments, or no other standard treatments are available.
- For certain parts of the study, participants must have specific types of cancer like non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, stomach cancer, kidney cancer, or bladder cancer.
- Must have good blood, liver, and kidney function and be in generally good health.
- For some groups, participants must have specific genetic markers or have tried certain treatments before.
- Must not have certain genetic mutations if they have non-squamous NSCLC.
- Must meet specific criteria for PD-L1 protein levels in their tumors.
Exclusion Criteria
- Have previously been treated with OX40 agonists.
- Have received other cancer treatments or investigational drugs recently, with some exceptions.
- Have blood cancers or other types of cancer that could interfere with the study.
- Have active cancer in the brain or spinal cord, unless treated and stable.
- Have had severe immune-related side effects from previous treatments.
- Have active autoimmune diseases requiring treatment with steroids or other medications.
- Have a history of certain infections like hepatitis B, hepatitis C, or HIV, unless exceptions apply.
- Have lung diseases like interstitial lung disease or pneumonitis.
- Have serious heart conditions or uncontrolled high blood pressure.
- Have had a significant blood clot in the lungs recently.
- Have had major surgery recently.
- Have had recent treatments for infections.
- Have had organ or stem cell transplants.
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