Recruiting
Phase 1

CBI-1214

Sponsor:

Cartography Biosciences

Code:

NCT07321106

Conditions

Colorectal Cancer

Colorectal Cancer (CRC)

Colorectal (Colon or Rectal) Cancer

CRC

Metastatic Colon Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBI-1214

Study Details

Brief 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

Conditions

Colorectal Cancer

Colorectal Cancer (CRC)

Colorectal (Colon or Rectal) Cancer

CRC

Metastatic Colon Cancer

Study ID

NCT07321106

Start date

Jan 15, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation and optimization trial of CBI-1214

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.

Interventions

CBI-1214

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.

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 ]
  • To determine the MTD and/or OBD and select the recommended dose(s) of CBI-1214 for dose optimization [ Time Frame: Approximately 48 months ]

Central Contacts and Locations

Central contacts

Study Lead

833-318-4749clinicaltrials@cartography.bio

Locations

Mayo Clinic Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Clinical Trials Referral Office

855-776-0015Cable.Sarah@mayo.edu

Principal Investigator:

Mojun Zhu, MD

City of Hope Duarte

Recruiting

Duarte, California, United States, 91010

Contacts

Study Referral Coordinator

800-826-4673jestebane@coh.org

Principal Investigator:

Marwan Fakih, MD

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Rachel Andes

855-731-6040randes@mednet.ucla.edu

Principal Investigator:

J. Randolph Hecht, MD

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 91402

Contacts

Myo Zaw

424-565-1874myo.zaw@vctcare.com

Principal Investigator:

David Berz, MD, PhD, MPH

UCSF

Recruiting

San Francisco, California, United States, 94158

Contacts

UCSF Team

415-353-2051HDFCCC.CIRCT@ucsf.edu

Principal Investigator:

David Oh, MD, PhD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015Nussbaum.Samuel@mayo.edu

Principal Investigator:

Conor D O'Donnell, MB, BCh, BAO

Emory Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Study Referral Coordinator

404-778-1900winship.referrals@emoryhealthcare.org

Principal Investigator:

Olatunji Alese, MD

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Julie Reish

616-954-5554hopeteam@startresearch.com

Principal Investigator:

Manish Sharma, MD

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jordan Georg

(210) 580-9521jgeorg@nextoncology.com

Principal Investigator:

David Sommerhalder, MD

NEXT Oncology

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

(703) 783-4518mdelarosa@nextoncology.com

Principal Investigator:

Alexander Spira, MD, PhD

More Information

Sponsor

Cartography Biosciences

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Oncology
  • Solid Tumor
  • Phase 1
  • First-in-Human
  • Dose Escalation
  • Open-Label
  • T-Cell Engager
  • TCE
  • CartographyBio

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cartography Biosciences on 2026-08-26.