Study on ZN-c3 for Adults with Advanced Colorectal Cancer
Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
ClinicalTrials ID:NCT05743036
This clinical trial is testing a new treatment combination involving ZN-c3, encorafenib, and cetuximab to see if it is safe and beneficial for adults with advanced colorectal cancer that has a specific BRAF V600E mutation and has not responded to one or two previous treatments.
Patient Parameters
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Program Overview
The aim of this study is to determine if a new combination of drugs, including ZN-c3, encorafenib, and cetuximab, is safe and can provide clinical benefits for adults with advanced colorectal cancer that has a specific genetic mutation (BRAF V600E) and has not improved with one or two prior treatments.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced Stage IV colorectal cancer.
- Have a specific genetic mutation called BRAF V600E in the cancer cells.
- Have at least one tumor that can be measured using standard criteria.
- The cancer must have worsened after one or two previous treatments for advanced cancer.
- Have good bone marrow function.
- Have good liver and kidney function.
Exclusion Criteria
- Cancer has worsened during the screening period.
- Have cancer that has spread to the membranes surrounding the brain and spinal cord.
- Have symptoms from cancer that has spread to the brain.
- Have acute or chronic inflammation of the pancreas.
- Cannot swallow or absorb oral medications.
- Have serious heart diseases.
- Have active lung inflammation not caused by infection.
- Have an active and uncontrolled bacterial or viral infection within two weeks before starting the study treatment.
- Have HIV.
- Have active hepatitis B or C infection.
- Have another type of cancer within the last two years.
- Have had a tissue or organ transplant.
- Are pregnant or breastfeeding, or women who could become pregnant and have a positive pregnancy test within 14 days before joining the study.
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