Actively Recruiting
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Advanced or Metastatic MSS/MSI-L Colorectal Cancer
Led by Cartography Biosciences · Updated on 2026-05-29
80
Participants Needed
7
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes, and anti-tumor effects of a drug called CBI-1214 in adults with advanced or metastatic Microsatellite Stable (MSS) or Microsatellite Instability Low (MSI-L) colorectal cancer. This early-phase, first-in-human study focuses on participants whose cancer has not responded to at least one prior standard treatment. The study aims to find the best dose that balances safety and effectiveness for further research. Participants will receive CBI-1214, a biological therapy designed to connect their T cells to colorectal cancer cells to promote tumor cell killing. The study begins with a dose-escalation phase where participants are assigned to increasing doses of CBI-1214 sequentially. After completing dose escalation, a recommended dose will be selected for a dose-expansion phase to further evaluate the treatment. During the study, participants will be monitored for safety and tolerability over about 48 months while researchers measure how the drug behaves in the body and assess anti-tumor activity using several outcomes, including overall response rate, duration of response, progression-free survival, and overall survival. Participants will provide tissue samples and undergo regular assessments to track effects. The study is sponsored by Cartography Biosciences and includes detailed safety monitoring and long-term follow-up.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of Microsatellite Stable (MSS) or Microsatellite Instability Low (MSI-L) colorectal cancer
- Have exhausted at least one prior line of standard systemic therapy for current malignancy
- Participants with certain genomic aberrations must have received prior FDA-approved targeted therapies and experienced disease progression, refractoriness, or intolerance
- Able to provide archival or fresh biopsy tissue samples
You will not qualify if you...
- Colorectal cancer tumor tissues identified as deficient mismatch repair (dMMR) or Microsatellite Instability High (MSI-H)
- 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 requiring systemic treatment within past 2 years (excluding controlled endocrinopathy on hormone replacement)
- Recent infection within 4 weeks caused by specified pathogens
- Known seropositive for HIV, hepatitis B surface antigen, or hepatitis C antibody requiring antiviral therapy
- History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome
- Significant uncontrolled medical comorbidities including hypertension, unstable angina, congestive heart failure, severe arrhythmias, poorly controlled diabetes, severe pulmonary disease, recent coronary angioplasty or myocardial infarction, or uncontrolled cardiac arrhythmias
- Congenital long QT syndrome or corrected QT interval ≥480 ms unless due to pacemaker or bundle branch block
- Active second primary malignancy within 3 years except certain skin, prostate, cervical, or breast cancers
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to approximately 48 months
Participants receive escalating doses of CBI-1214 to evaluate safety, tolerability, and determine the optimal dose for treating advanced or metastatic MSS/MSI-L colorectal cancer.
Sequential dosing visits according to dose escalation and optimization schedules
Trial Site Locations
Total: 7 locations
1
City of Hope Duarte
Duarte, California, United States, 91010
Actively Recruiting
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 91402
Actively Recruiting
3
UCSF
San Francisco, California, United States, 94158
Actively Recruiting
4
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
6
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
7
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Study Lead
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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