RecruitingPhase 1NCT07321106

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

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


Sponsor

Cartography Biosciences

Enrollment

80 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called CBI-1214, which works by helping your immune system's T cells recognize and attack colon cancer cells. It is for people with advanced colorectal cancer that has not responded well to previous treatments. **You may be eligible if...** - You have advanced or metastatic colorectal cancer (a type called MSS or MSI-low) - You have already received at least one standard chemotherapy treatment that stopped working - If your tumor has specific genetic changes (like BRAF or HER2), you must have already tried those targeted treatments - You are able to provide a tumor tissue sample **You may NOT be eligible if...** - Your tumor is the type called MSI-high or mismatch repair deficient (dMMR) - You have untreated brain metastases - You have an active autoimmune disease requiring treatment in the last 2 years - You have had a recent serious viral infection (like shingles, EBV, or CMV) - You are HIV positive or have active hepatitis B or C requiring antiviral therapy - You have had a serious skin reaction to prior medications (like Stevens-Johnson syndrome) - You have a history of organ transplant 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

BIOLOGICALCBI-1214

CBI-1214 is a bispecific T cell engager that binds to LY6G6D and CD3. It is designed to link the patients T cells to cancer cells and to mediate tumor cell killing. LY6G6D is an emerging target specifically expressed on malignant colorectal cancer cells.


Locations(4)

Valkyrie Clinical Trials

Los Angeles, California, United States

START Midwest

Grand Rapids, Michigan, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07321106


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