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
18 Years and older, Male and Female
CBI-1214-001 (primary)
NCI-2026-01990
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
- 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
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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