NCT07321106 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
| NCT ID | NCT07321106 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Cartography Biosciences |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2026-01-15 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07321106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07321106 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07321106 currently recruiting?
Yes, NCT07321106 is actively recruiting participants. Contact the research team at clinicaltrials@cartography.bio for enrollment information.
Where is the NCT07321106 trial being conducted?
This trial is being conducted at Los Angeles, United States, Grand Rapids, United States, San Antonio, United States, Fairfax, United States.
Who is sponsoring the NCT07321106 clinical trial?
NCT07321106 is sponsored by Cartography Biosciences. The trial plans to enroll 80 participants.
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