New t cell engager takes on tough colorectal cancer
NCT ID NCT07321106
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times
Summary
This early-phase trial tests a new drug called CBI-1214 in 80 people with advanced colorectal cancer that has not responded to standard treatments. CBI-1214 is designed to connect the body's own immune T cells to cancer cells, helping the immune system attack the tumor. The main goals are to check safety, find the right dose, and see if the drug can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CBI-1214 (a T cell engager that links immune cells to cancer cells)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced colorectal cancer that is hard to treat with current therapies.
- What could go wrong
- This is a very early, first-in-human trial with only 80 participants. The drug may not shrink tumors or could cause significant side effects. Many early-stage cancer drugs do not advance to later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced colorectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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City of Hope Duarte
RECRUITINGDuarte, California, 91010, United States
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Emory Winship Cancer Institute
RECRUITINGAtlanta, Georgia, 30322, United States
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Mayo Clinic Arizona
RECRUITINGPhoenix, Arizona, 85054, United States
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Mayo Clinic Florida
RECRUITINGJacksonville, Florida, 32224, United States
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NEXT Oncology
RECRUITINGSan Antonio, Texas, 78229, United States
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NEXT Oncology
RECRUITINGFairfax, Virginia, 22031, United States
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START Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
Contact Email: •••••@•••••
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UCLA
RECRUITINGLos Angeles, California, 90095, United States
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UCSF
RECRUITINGSan Francisco, California, 94158, United States
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Valkyrie Clinical Trials
RECRUITINGLos Angeles, California, 91402, United States
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