Study on BXQ-350 for Newly Diagnosed Metastatic Colorectal Cancer
Sponsor: Bexion Pharmaceuticals, Inc.
ClinicalTrials ID:NCT05322590
This clinical trial is testing a new treatment, BXQ-350, combined with standard chemotherapy and bevacizumab, for patients with newly diagnosed metastatic colorectal cancer. The study aims to see if this combination can safely and effectively treat the cancer and reduce nerve-related side effects from chemotherapy.
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Program Overview
The study is exploring the safety and effectiveness of a new treatment called BXQ-350, used alongside standard chemotherapy (mFOLFOX7) and bevacizumab, for patients with newly diagnosed metastatic colorectal cancer. Researchers want to find out if BXQ-350 can help reduce nerve damage caused by chemotherapy, allowing patients to complete their full treatment plan. All participants will receive BXQ-350 through an IV, along with standard chemotherapy and bevacizumab. The study has two parts: the first part will test different doses of BXQ-350 to find the best one, and the second part will compare the effects of BXQ-350 to a placebo.
Description
BXQ-350 is a new type of cancer treatment made from a protein and a lipid, which are natural components of cells. It is designed to work by affecting certain molecules in the body that are involved in cancer growth and inflammation. In lab tests, BXQ-350 has shown potential to protect nerve cells and reduce nerve pain caused by chemotherapy. This makes it a promising option to use with standard treatments for metastatic colorectal cancer, not only to improve cancer treatment but also to help manage side effects like nerve damage from chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a new diagnosis of Stage IV metastatic colorectal cancer.
- Have cancer that can be measured by scans.
- Have a life expectancy of more than 3 months.
- Be in good overall health, with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have acceptable liver function, with specific blood test results within normal limits.
- Have acceptable kidney function, with creatinine clearance of at least 50 mL/minute.
- Have acceptable bone marrow function, with specific blood cell counts above certain levels.
- Have normal blood clotting times unless on anticoagulation.
- Women of childbearing potential must have a negative pregnancy test and use effective contraception.
- Agree to use effective contraception during the study and for a period after the last dose of the study drug.
- Be able to give informed consent and comply with study requirements.
Exclusion Criteria
- Have a specific type of colorectal cancer with DNA-mismatch repair deficiency or high microsatellite instability.
- Have brain metastases unless stable for at least 4 weeks and off steroids for 7 days.
- Have another cancer within the past 5 years that affects life expectancy or disease assessment.
- Have diabetes (Type 1 or 2).
- Have a history of certain brain conditions or active gastrointestinal issues.
- Have a family history of genetic nerve disorders.
- Have existing nerve damage from any cause.
- Have had major surgery within 28 days or not recovered from surgery side effects.
- Have uncontrolled high blood pressure.
- Have a history of serious heart problems.
- Have uncontrolled infections, including HIV or hepatitis.
- Have active poor wound healing or significant bleeding issues.
- Be pregnant or breastfeeding.
- Have other severe medical conditions that could interfere with the study.
- Have received certain treatments or medications that could affect the study results.
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