Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT05824559
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Histological or cytological documentation of adenocarcinoma of the colon or rectum that is metastatic (all other histological types are excluded)
* Subjects who progressed or demonstrated intolerability to prior standard approved therapies which include fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapies, cetuximab/panitumumab (if clinically indicated e.g., RAS wild-type tumors) PD-1 or BRAF inhibitors (if clinically indicated), and/or other checkpoint inhibitors in the metastatic setting.
* Previous treatment with any investigational drug or anticancer treatment must be completed \>28 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
* Adequate bone marrow, liver, and renal function
Exclusion Criteria:
* Untreated brain metastases, spinal cord compression, or primary brain tumor
* Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor
* Evidence of uncontrolled or unstable cardiovascular disease, myocardial infarction (within 6 months), unstable angina pectoris, congestive heart failure, serious arrhythmias requiring drug therapy
* History of CNS disease
* Bevacizumab or aflibercept therapy ≤ 3 weeks prior to starting study treatment
* Peripheral neuropathy Grade ≥ 2
* Uncontrolled hypertension or diabetes mellitus, active peptic ulcers, unhealed wounds, clinically significant disease or systemic infections
* Known seropositive for, or active infection with hepatitis B or C virus
* Symptomatic or uncontrolled infection with human T-cell leukemia virus
* Venous thromboembolism (unless appropriately treated and stable on anticoagulant for at least 2 weeks).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05824559
Study Brief:
Protocol Section:
NCT05824559