CBI-1214 T-cell engager for advanced MSS/MSI-L colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, phase 1 dose-escalation trial gives increasing doses of CBI-1214 to people with advanced or metastatic MSS/MSI-L colorectal cancer to measure safety, tolerability, pharmacokinetics, and any anti-tumor activity. Eligible participants must have received at least one prior line of standard systemic therapy and provide an archival tumor sample or undergo a fresh biopsy. The trial excludes MSI-High/dMMR tumors and people with certain conditions such as prior solid organ transplant or active interstitial lung disease. Study procedures include regular blood sampling, imaging to track tumor response, and close monitoring for adverse events.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• City of Hope Duarte
  Duarte, California, United States Recruiting
• UCLA
  Los Angeles, California, United States Recruiting
• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting
• UCSF
  San Francisco, California, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Study Lead
• Email: clinicaltrials@cartography.bio
• Phone: 833-318-4749

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.