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CBI-1214 for Advanced Colorectal Cancer

This study is testing a new treatment called CBI-1214 for people with advanced or metastatic (spread to other parts of the body) colorectal cancer. CBI-1214 is designed to help your body's immune cells (T cells) find and kill cancer cells by targeting a specific marker called LY6G6D on the cancer cells. Researchers want to see how safe CBI-1214 is, what side effects it might cause, and how well your body handles it. They also want to find the best dose and see if it can shrink tumors. You might be able to join if you have Microsatellite Stable (MSS) or Microsatellite Instability Low (MSI-L) colorectal cancer and have already tried at least one other treatment. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 80 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for safety and dose determination are measured at approximately 48 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07321106

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Cartography Biosciences
~80 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:CBI-1214

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the safety and tolerability of CBI-1214 at increasing dose levels and optimized dose levels in participants with advanced or metastatic MSS/MSI-L CRC
Measured over Approximately 48 months
+1 more outcome measured

Conditions

Colorectal Cancer
Colorectal Cancer (CRC)
Colorectal (Colon or Rectal) Cancer
CRC
Metastatic Colon Cancer
Colon Cancer
Advanced Colorectal Cancer

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Where it's being run

10 sites across 7 states
California4
Arizona1
Florida1
Georgia1
Michigan1
Texas1
Virginia1

Who to contact

Study Lead
[email protected]
833-318-4749
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant with MSS/MSI-L CRC, who has exhausted at least one prior line of standard systemic therapy for their current malignancy.
Participant with genomic aberrations, including but not limited to BRAFV600E mutations and HER2 amplifications, for which FDA-approved targeted therapies are available, must:
Have received prior treatment with applicable FDA-approved targeted therapies AND
Either have experienced disease progression, be refractory, or be intolerant to directed molecular therapy.
Participant able to provide archival tissue sample or fresh biopsy tissue sample

Exclusion

Participant whose CRC tumor tissues have been identified as dMMR or MSI-H
Known history of solid organ or tissue transplant; history of interstitial lung disease or non-infectious pneumonitis.
Untreated central nervous system (CNS) metastatic disease.
Active autoimmune disease that has required systemic treatment within the past 2 years (participants with hormone replacement therapy for adequately controlled endocrinopathy are allowed in the study).
History of recent infection (within 4 weeks of C1D1) considered to be caused by one of the pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68.
Known seropositive for human immunodeficiency virus, hepatitis B surface antigen, or antibody to hepatitis C virus with confirmatory testing and requiring anti-viral therapy.
History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure \>115 mm Hg), unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, or myocardial infarction within 6 months prior to screening, or uncontrolled atrial or ventricular cardiac arrhythmias.
Congenital long QT syndrome or a corrected QT interval (QTc) ≥480 ms at screening (unless secondary to pacemaker or bundle branch block).
Active second primary malignancy within 3 years of Screening other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast

What this trial measures

  • To evaluate the safety and tolerability of CBI-1214 at increasing dose levels and optimized dose levels in participants with advanced or metastatic MSS/MSI-L CRCApproximately 48 months

    Incidence and severity of TEAEs, TRAEs, and TESAEs; changes in vital signs, physical examinations, and clinical laboratory parameters per NCI-CTCAE v5.0.

  • To determine the MTD and/or OBD and select the recommended dose(s) of CBI-1214 for dose optimizationApproximately 48 months

    Incidence of DLTs observed during the first treatment cycle