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Colorectal CancerPhase 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 study testing CBI-1214 in people with Colorectal Cancer and Colorectal Cancer (CRC), run by Cartography Biosciences at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CBI-1214
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
10 sitesUnited States
Study dates
15 Jan 2026to Oct 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Lead contact

833-318-4749

clinicaltrials@cartography.bio

10 sites in 1 country

United States10 sites, 10 recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

    Study Referral Coordinator, 404-778-1900, winship.referrals@emoryhealthcare.org

    Olatunji Alese, MD

    Recruiting

  • City of Hope Duarte

    Duarte, California, 91010

    Study Referral Coordinator, 800-826-4673, jestebane@coh.org

    Marwan Fakih, MD

    Recruiting

  • NEXT Oncology

    Fairfax, Virginia, 22031

    Maybelle De La Rosa, (703) 783-4518, mdelarosa@nextoncology.com

    Alexander Spira, MD, PhD

    Recruiting

  • START Midwest

    Grand Rapids, Michigan, 49546

    Julie Reish, 616-954-5554, hopeteam@startresearch.com

    Manish Sharma, MD

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Clinical Trials Referral Office, 855-776-0015, Nussbaum.Samuel@mayo.edu

    Conor D O'Donnell, MB, BCh, BAO

    Recruiting

  • UCLA

    Los Angeles, California, 90095

    Rachel Andes, 855-731-6040, randes@mednet.ucla.edu

    J. Randolph Hecht, MD

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 91402

    Myo Zaw, 424-565-1874, myo.zaw@vctcare.com

    David Berz, MD, PhD, MPH

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Clinical Trials Referral Office, 855-776-0015, Cable.Sarah@mayo.edu

    Mojun Zhu, MD

    Recruiting

  • NEXT Oncology

    San Antonio, Texas, 78229

    Jordan Georg, (210) 580-9521, jgeorg@nextoncology.com

    David Sommerhalder, MD

    Recruiting

  • UCSF

    San Francisco, California, 94158

    UCSF Team, 415-353-2051, HDFCCC.CIRCT@ucsf.edu

    David Oh, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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

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

Being tested
CBI-1214
Keywords
Oncology, Solid Tumor, Phase 1, First-in-Human, Dose Escalation, Open-Label, T-Cell Engager, TCE, CartographyBio
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBI-1214Biological

    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.

Study groups in NCT07321106
Study groupRoleWhat they receive
Dose escalation and optimization trial of CBI-1214ExperimentalParticipants 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.
Receives: Biological: CBI-1214

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

    Measured: Approximately 48 months

  2. To determine the MTD and/or OBD and select the recommended dose(s) of CBI-1214 for dose optimization

    Incidence of DLTs observed during the first treatment cycle

    Measured: Approximately 48 months

Secondary outcomes (7)

  1. To characterize the Serum Concentration of CBI-1214.

    Serum concentration of CBI-1214 at specified timepoints following a single infusion as well as following repeat infusions.

    Measured: Approximately 48 months

  2. Overall Response Rate (ORR)

    ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    Measured: Approximately 48 months

  3. Duration of Response (DOR)

    Duration of response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1

    Measured: Approximately 48 months

  4. Progression Free Survival (PFS)

    The time from the date of first dose of study treatment to the first documentation of disease progression as determined by RECIST version 1.1, or death from any cause, whichever occurs first.

    Measured: Approximately 48 months

  5. Time to Response (TTR)

    The time from the date of first dose of study treatment to the first documented evidence of objective tumor response (Complete Response [CR] or Partial Response [PR]) as assessed per RECIST version 1.1.

    Measured: Approximately 48 months

  6. Clinical Benefit Rate (CBR)

    The proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) lasting for a minimum prespecified duration (e.g., ≥12 or ≥16 weeks) as determined by RECIST version 1.1.

    Measured: Approximately 48 months

  7. Overall Survival (OS)

    The time from the date of first dose of study treatment to death from any cause.

    Measured: Approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start15 Jan 2026
  3. Primary completionApr 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07321106
Sponsor's protocol ID
CBI-1214-001
Status last verified
Aug 2026
First submitted
15 Dec 2025
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CBI-1214 in people with Colorectal Cancer and Colorectal Cancer (CRC), run by Cartography Biosciences at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Lead (833-318-4749, clinicaltrials@cartography.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Approximately 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07321106.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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