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A Phase 1, First-in-human (FIH), Dose-Escalation and Dose-Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer

What is this study?

This study is testing a new experimental drug called CBI-1214 to see if it is safe and effective for patients with advanced colorectal cancer. It is designed for patients whose specific type of cancer has not responded well to standard treatments, offering a potential new way to fight the disease.

Who can participate?

This trial is for adults with a specific type of colorectal cancer (MSS/MSI-L) that has spread or continued to grow after previous treatments. You must be able to provide a tumor sample and meet specific health criteria regarding your immune system and overall health.

What will happen?

Participants will receive the experimental drug CBI-1214 and have their health closely monitored by a team of doctors to track safety and how the body processes the medication. You will undergo regular check-ups and testing to see how your cancer responds to the new treatment.

Where and when?

The study is currently recruiting new participants and is being held at specialized medical centers in Duarte and Los Angeles, California. Researchers are actively looking for patients to join this important first-in-human trial.

Key Points
  • 1The drug works by helping your own immune system find and fight cancer cells.
  • 2Participation requires having a confirmed diagnosis of MSS/MSI-L colorectal cancer.
  • 3Your medical history and previous treatments are carefully reviewed to ensure the study is a safe fit for you.

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Conditions Studied
This study is investigating treatments for the following conditions
Colorectal CancerColorectal Cancer (CRC)Colorectal (Colon or Rectal) CancerCRCMetastatic Colon CancerColon CancerAdvanced Colorectal Cancer

This summary was generated using AI and may not capture all details. Always consult with a healthcare professional for medical advice.