Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing CBI-1214, a T-cell engager designed to bring immune T cells into contact with cancer cells, in people with advanced or metastatic colorectal cancer that is microsatellite stable or has low microsatellite instability. They will give increasing doses to learn how the drug behaves in the body and whether it shows signs of anti-tumour activity.
The idea is that directing T cells toward the cancer could produce tumour control in cancers that have generally been less responsive to some immune treatments. The main measure is safety and tolerability at different doses, rather than whether patients live longer or go longer before the cancer grows.
Worth knowing: This is a small, non-randomised phase 1 trial with no comparison group, so it is primarily testing safety and dose—not establishing benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07321106 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 80 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Cartography Biosciences |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological CBI-1214
What it is 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
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
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
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Rectal
- Colon
- Already treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
- 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 Criteria
The main exclusion criteria include but are not limited to the following:
- 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,…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 10 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07321106, registered by Cartography Biosciences on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.