CBI-1214 for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called CBI-1214, a potential drug for individuals with advanced or metastatic colorectal cancer that is Microsatellite Stable (MSS) or has Low Microsatellite Instability (MSI-L). The main goal is to assess the safety and tolerability of CBI-1214 and evaluate its effectiveness against tumors. Participants will receive varying doses to determine the optimal amount. The trial seeks individuals who have tried at least one standard treatment without success and have specific genetic changes, such as BRAFV600E mutations. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that CBI-1214 is likely to be safe for humans?
Research shows that CBI-1214 is under study to assess its safety and tolerability. As this is an early-stage study, limited information is available. The trial aims to determine the optimal dose that patients can tolerate with minimal side effects.
CBI-1214 is in its first phase of testing, marking its initial trial in humans. This phase focuses on ensuring the treatment's safety before proceeding to larger studies. Consequently, detailed safety information is not yet available. The goal is to understand how the treatment interacts with the body and to identify any adverse reactions. Participants will receive increasing doses to find the most effective yet safe dose.
Prospective participants should know that researchers will closely monitor all participants for side effects, ensuring careful management of any risks.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for colorectal cancer, which often include chemotherapy, radiation, and surgery, CBI-1214 represents a novel approach. Researchers are excited about CBI-1214 because it offers a new mechanism of action that targets the cancer cells differently, potentially improving treatment outcomes. This experimental drug is being tested in a dose-escalation format to find the optimal dose, which could lead to more effective and tailored treatment options for patients.
What evidence suggests that CBI-1214 might be an effective treatment for colorectal cancer?
Research shows that CBI-1214 uses a new technology to help the immune system find and attack cancer cells in colorectal cancer. The FDA has fast-tracked CBI-1214 due to its promise in fighting tumors. Early studies suggest it might work when standard treatments have not. While more information is needed, CBI-1214 is specifically designed to enhance the body's ability to fight cancer. Participants in this trial will receive escalating doses of CBI-1214 sequentially to determine the optimal dose for further study.15678
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic MSS/MSI-L colorectal cancer who have already tried at least one standard treatment without success. They should have also used approved targeted therapies and either progressed, not responded, or couldn't tolerate them. Participants must be able to provide a tissue sample from previous tests or agree to a new biopsy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation and Optimization
Participants will be assigned sequentially to escalating doses of CBI-1214. Once dose escalation is completed, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CBI-1214
Trial Overview
The study is testing CBI-1214, which is designed to engage T cells in fighting the tumor. It aims to evaluate how safe it is, how well patients can handle it, what happens to the drug in the body (pharmacokinetics), and if it's effective against this type of colorectal cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will be assigned sequentially to escalating doses of CBI-1214. Once dose escalation is completed, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cartography Biosciences
Lead Sponsor
Citations
NCT07321106 | A Study to Investigate the Safety, ...
This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic ...
CBI-1214 Receives IND and FTD for Colorectal Cancer
FDA approves CBI-1214 for colorectal cancer, enabling fast-tracked clinical trials and highlighting innovative T-cell engager technology.
CBI-1214 for Colorectal Cancer
This trial is for adults with advanced or metastatic MSS/MSI-L colorectal cancer who have already tried at least one standard treatment without success. They ...
4.
finance.yahoo.com
finance.yahoo.com/news/cartography-receives-fda-investigational-drug-123000726.htmlCartography Receives FDA Investigational New Drug (IND) ...
CBI-1214 has protein engineering features that are specifically designed to optimize anti-tumor activity. About Colorectal Cancer. Colorectal ...
5.
oncologynewscentral.com
oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-december-2025Oncology Drugs Fast-Tracked by the FDA in December 2025
CBI-1214 for Colorectal Cancer. On Dec. 18, Cartography Biosciences ... data reveal serious risks, including those from reduced effectiveness.
CBI-1214 - A Study to Investigate the Safety, Tolerability, ...
This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or ...
A Study to Investigate the Safety, Tolerability, ...
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 ...
8.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-anti-tumor-activity-of-cbi12A Study to Investigate the Safety, Tolerability ...
This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or ...
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