RecruitingPhase 2NCT06225843

Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis

A Proof-of-Concept Phase II Trial to Evaluate the EMT Inhibitor Sotevtamab Combined With FOLFOX Administered as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis


Sponsor

Alethia Biotherapeutics

Enrollment

17 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This Phase II study will recruit 17 colorectal cancer patients with liver-dominant metastases. All recruited patients will receive Sotevtamab at a dose of 800 mg once weekly for 6 cycles combined with FOLFOX once every 2 weeks for the first 4 cycles followed by liver metastases resection surgery with or without primary cancer resection. One cycle of treatment will consist of 14 days (2 weeks).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called sotevtamab combined with a standard chemotherapy regimen called FOLFOX to treat colorectal cancer that has spread to the liver. The goal is to shrink the tumors before surgery to remove them. **You may be eligible if...** - You are 18 or older with stage IV colon or rectal cancer that has spread mainly to the liver - Your liver tumors are considered removable by surgery - You have not had chemotherapy for metastatic disease - You are in reasonably good physical condition (able to carry out normal activities) - You have adequate liver, kidney, and immune function **You may NOT be eligible if...** - Your tumor has a specific genetic defect called MMR-deficiency - You have hereditary colorectal cancer syndromes (like Lynch syndrome or familial polyposis) - You have an active HIV, Hepatitis B, or Hepatitis C infection - You are pregnant or breastfeeding - You have pre-existing nerve damage in your hands or feet - You are currently taking high-dose immune-suppressing medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSotevtamab

Sotevtamab is an inhibitor of the epithelial to mesenchymal transition. It is a fully humanized monoclonal antibody of IgG2 isotype against tumor-associated secreted clusterin (TA-sCLU)

COMBINATION_PRODUCTFOLFOX

FOLFOX is a chemotherapy regimen for treatment of colorectal cancer, made up of the drugs folinic acid, fluorouracil, and oxaliplatin.


Locations(1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

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NCT06225843


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