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Tests treatment safety and results for Colorectal Cancer
Official title 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
ClinicalTrials.gov ID: NCT07321106
What this study is testing
What is CBI-1214?
CBI-1214 is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main 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...
- 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.
You likely can't join 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...
- 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...
See the full eligibility criteria
- The main 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Atlanta, Georgia, United States
- Grand Rapids, Michigan, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Atlanta, Georgia, United States; Grand Rapids, Michigan, United States; San Antonio, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.