A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Xilonix; Placebo
Intervention description: Xilonix is a True Human Monoclonal Antibody targeting Interleukin 1 alpha, and is administered intravenously every 2 weeks with best supportive care until clinical or radiographic progression.; Placebo plus best supportive care will be administered intravenously every 2 weeks until clinical or radiographic progression.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 643.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pivotal; Colorectal; Survival; Phase 3

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Subjects will not be treated with any radiation, chemotherapy, or investigational
             agents while enrolled in this protocol.

          3. Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.

          4. At least 2 weeks since the last previous cancer treatment including: chemotherapy,
             radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics.

          5. Age ≥ 18 years, male or female subjects.

          6. 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.

          7. Adequate renal function, defined by serum creatinine ≤ 1.5 x ULN.

          8. Adequate hepatic function

          9. Adequate bone marrow function

         10. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at
             Screening.

         11. Signed and dated institutional review board (IRB)-approved informed consent before any
             protocol-specific screening procedures are performed.

         12. Patients enrolled must, in the Investigator's judgment, be healthy enough to stay on
             the clinical trial for three months.

        Exclusion Criteria:

          1. Mechanical obstruction that would prevent adequate oral nutritional intake.

          2. Serious uncontrolled medical disorder, or active infection, that would impair the
             ability of the patient to receive protocol therapy.

          3. Uncontrolled or significant cardiovascular disease, including:

          4. Dementia or altered mental status that would prohibit the understanding or rendering
             of informed consent.

          5. 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.

          6. Immunocompromised subjects, including subjects known to be infected with human
             immunodeficiency virus (HIV).

          7. Known hepatitis B surface antigen and/or positive hepatitis C antibody and presence of
             hepatitis C RNA.

          8. History of tuberculosis (latent or active) or positive Interferon-gamma release assay
             (IGRA).

          9. Receipt of a live (attenuated) vaccine within 1 month prior to Screening

         10. Subjects with history of hypersensitivity to compounds of similar chemical or biologic
             composition of XILONIX™.

         11. Women who are pregnant or breastfeeding.

         12. 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.

         13. Weight loss >20% in the previous 6 months.