Actively Recruiting
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
Led by Cartography Biosciences · Updated on 2026-03-03
80
Participants Needed
4
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 with advanced or metastatic Microsatellite Stable (MSS) or Microsatellite Instability Low (MSI-L) colorectal cancer
- Must have received at least one prior line of standard systemic therapy for current malignancy
- Participants with genomic alterations like BRAFV600E mutations or HER2 amplifications must have received FDA-approved targeted therapies and experienced disease progression, refractory disease, or intolerance to those therapies
- Ability to provide an archival or fresh biopsy tissue sample
You will not qualify if you...
- Colorectal cancer tumors identified as mismatch repair deficient (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 metastatic disease
- Active autoimmune disease requiring systemic treatment within the past 2 years (except controlled endocrinopathy on hormone replacement)
- Recent infection within 4 weeks caused by specified viruses or bacteria
- Known HIV, hepatitis B, or hepatitis C infection requiring antiviral therapy
- History of Steven's Johnson's syndrome or toxic epidermal necrolysis
- Significant uncontrolled medical conditions including severe hypertension, unstable angina, congestive heart failure beyond NYHA class II, severe arrhythmias, recent coronary events, uncontrolled diabetes, severe chronic lung disease
- Congenital long QT syndrome or corrected QT interval 60 ms at screening (unless due to pacemaker or bundle branch block)
- Active second primary cancer within 3 years except certain skin, prostate, cervical, or breast cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Valkyrie Clinical Trials
Los Angeles, California, United States, 91402
Actively Recruiting
2
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
4
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Study Lead
CONTACT
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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