RecruitingPhase 1

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

A Phase 1, First-in-human (FIH), Dose-Escalation and Dose-Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CBI-1214 for advanced colon or rectal cancer, including cancer that has spread. It is for people whose cancer has an MSS or MSI-L test result, meaning certain DNA changes are absent or low. Researchers will study safety, side effects, how the body handles the drug, and its effects on tumors.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have MSS or MSI-L colon or rectal cancer and have used up at least one standard drug treatment for this cancer.
  • If your cancer has gene changes with FDA-approved targeted treatments, you must have tried those treatments. The cancer must have grown, not responded, or the side effects must have been too hard to tolerate.
  • Be able to provide a stored tumor sample or a new sample taken through a biopsy.

Who can't join

  • Your tumor has dMMR or MSI-H test results, which show problems with DNA repair or high levels of certain DNA changes.
  • You have had an organ or tissue transplant, lung tissue disease or swelling not caused by infection, or Stevens-Johnson syndrome or toxic epidermal necrolysis—severe skin reactions.
  • You have untreated cancer that has spread to the brain or spinal cord.
  • You have an active disease where the immune system attacks the body and needed whole-body treatment in the past 2 years. Hormone replacement for a well-controlled hormone disorder is allowed.
  • Within 4 weeks before the first dose, you had an infection thought to be caused by HSV1, HSV2, VZV, EBV, CMV, measles, influenza A, Zika, Chikungunya, Mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68.
  • You have positive blood tests for HIV, hepatitis B, or confirmed hepatitis C and need antiviral treatment.
  • You have serious health problems, such as uncontrolled blood pressure, certain heart problems, poorly controlled diabetes, or severe long-term lung disease. This includes a heart attack or a procedure to open heart arteries within 6 months before screening. Inherited long QT syndrome or a QTc of 480 milliseconds or more—a heart rhythm test result—also excludes you, unless due to a pacemaker or a heart signal block.
  • You had another active cancer within 3 years before screening. Exceptions include non-melanoma skin cancer, prostate cancer that has not spread, and early cancers confined to the cervix or breast ducts or lobules.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (10)

AZ

CA

FL

GA

MI

TX

VA