|Pending||Metastatic Colorectal Cancer||Phase III||
The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy.
- Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have experienced progression (or intolerance) after treatment with standard approved regimens including, oxaliplatin, irinotecan flouropyrimidine, bevacizumab, and cetuximab or panitumumab if KRAS wildtype.
- Subjects will not be treated with any radiation, chemotherapy, or investigational agents while enrolled in this protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.
- At least 2 weeks since the last previous cancer treatment including: chemotherapy, radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics.
- Age ≥ 18 years, male or female subjects.
- Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal.
- Adequate renal function, defined by serum creatinine ≤ 1.5 x ULN.
- Adequate hepatic function
- Adequate bone marrow function
- For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
- Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed.
- Patients enrolled must, in the Investigator's judgment, be healthy enough to stay on the clinical trial for three months.
- Mechanical obstruction that would prevent adequate oral nutritional intake.
- Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.
- Uncontrolled or significant cardiovascular disease, including:
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- Subjects who have not recovered from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1; excluding alopecia and grade 2 neuropathy.
- Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV).
- Known hepatitis B surface antigen and/or positive hepatitis C antibody and presence of hepatitis C RNA.
- History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA).
- Receipt of a live (attenuated) vaccine within 1 month prior to Screening
- Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition of XILONIX™.
- Women who are pregnant or breastfeeding.
- WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication.
- Weight loss >20% in the previous 6 months.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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