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

Recruiting now · Phase 1

Conditions studied: Colorectal Cancer, Colorectal Cancer (CRC), Colorectal (Colon or Rectal) Cancer, CRC, Metastatic Colon Cancer, Colon Cancer, Advanced Colorectal Cancer

In brief

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

Key facts

Study ID

NCT07321106

Run by

Cartography Biosciences

People needed

80

Starts

2026-01-15

Expected to finish

2029-10-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States (enrolling)
• City of Hope Duarte — Duarte, California, United States (enrolling)
• UCLA — Los Angeles, California, United States (enrolling)
• Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
• UCSF — San Francisco, California, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• Emory Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• NEXT Oncology — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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