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

NCT07321106 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CBI-1214-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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 (Colon or Rectal) Cancer; CRC; Metastatic Colon Cancer; Colon Cancer; Advanced Colorectal Cancer; Colorectal Cancer; Colorectal Cancer (CRC)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Approximately 48 months

• 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

  Approximately 48 months

Secondary Outcomes (7)

• To characterize the Serum Concentration of CBI-1214.

  Approximately 48 months

• Overall Response Rate (ORR)

  Approximately 48 months

• Duration of Response (DOR)

  Approximately 48 months

• Progression Free Survival (PFS)

  Approximately 48 months

• Time to Response (TTR)

  Approximately 48 months

Study Arms (1)

Dose escalation and optimization trial of CBI-1214

EXPERIMENTAL

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.

Biological: CBI-1214

Interventions

CBI-1214 BIOLOGICAL

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.

Dose escalation and optimization trial of CBI-1214

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cartography Biosciences: lead

Study Sites (4)

Valkyrie Clinical Trials

Los Angeles, California, 91402, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Study Lead

CONTACT

833-318-4749; clinicaltrials@cartography.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 6, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)