RecruitingColorectal CancerColorectal Cancer (CRC)Colorectal (Colon or Rectal) Cancer
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
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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
Sponsor: Cartography Biosciences
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07321106 · last updated 2026-07-28