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Phase I study in patients with metastatic colorectal cancer with liver metastasis under second or third line therapy to examine safety, efficacy, and immune biomarkers after treatment with VXM01
Enrollment
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Inclusion criteria
Informed consent, including liver metastasis biopsy, signed and dated
Histologically or cytologically confirmed colorectal cancer, excluding primary tumors of appendiceal origin (participants are eligible to enroll irrespective of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status)
Male or female patients who must be post-menopausal for at least 2 years or surgically sterile.
Confirmed metastatic colorectal cancer (Stage IV)
Presence of non-resectable liver metastasis
The participant has received first-line irinotecan- or oxaliplatin-based therapy without or in combination with a targeted antibody for metastatic disease and a) Experienced radiographic disease progression during first-line therapy, or b) Experienced radiographic disease progression ≤ 6 months after the last dose of first-line therapy, or c) Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression ≤ 6 months after the last dose of first-line therapy
Receipt of no more than 3 prior systemic therapy regimen for metastatic disease
Measurable or non-measurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v. 1.1)
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy > 3 months
Adequate renal, hepatic, and bone marrow function
Leukocytes ≥4.0 x 109 / L
Absolute neutrophil count (ANC) > 1,500/mm3
Platelet count ≥ 100,000/mm3
Hemoglobin ≥ 9 g/dL (can be post-transfusion)
International normalized ratio (INR) ≤ 1.5
Activated partial thromboplastin time (aPTT) ≤ 1.5 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
ALT and AST ≤ 2.5 times ULN
Creatinine ≤ 2.0 mg/dL
Proteinuria ≤ 1+ by urine dipstick OR ≤ 1 g by 24-hour urine collection
Patients who are able to understand the nature and purpose of the study including possible risks, willing to comply with the requirements, and to provide their written informed consent to participate in the study
Exclusion criteria
Concomitant treatment with anti-angiogenic therapy before progression of disease
Treatment in any other clinical trial within 30 days before screening.
Gastric bypass
Ileostoma
Other anatomical change of the gastrointestinal tract, interfering with gastrointestinal passage, except colostoma or colon bypass
Untreated CNS metastases. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. No evidence of Grade greater than or equal to 1 CNS hemorrhage based on pretreatment Magnetic Resonance Imaging (MRI) or intravenous (IV) contrast CT scan
Significant traumatic injury or surgery within the past 4 weeks
Cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
Other malignancies within the past 5 years except for adequately treated carcinoma in situ of the cervix, and/or basal cell skin cancer, and/or early endometrial carcinoma
Pre-existing sensory or motor neuropathy ≥ grade 2
History or evidence of CNS disease (e.g., uncontrolled seizures) by neurological examination unless adequately treated with standard medical therapy
History or evidence of thrombotic or hemorrhagic disorders, including intracranial hemorrhage
Uncontrolled hypertension (i.e., blood pressure > 160/100 mm Hg)
Clinically significant cardiovascular disease, including any of the following:
Peripheral vascular disease ≥ grade 3 (i.e., symptomatic and interfering with activities of daily living requiring repair or revision)
Positive for anti-typhoid IgG/IgM antibodies according to the onsite test on Day 0
Hemoptysis within 6 months before randomization
Esophageal varices
Upper or lower gastrointestinal bleeding within 6 months before randomization
Non-healing wound, incomplete wound healing, bone fracture or any history of gastrointestinal ulcers within three years before inclusion, or positive gastroscopy within 3 months before inclusion
Gastrointestinal fistula
Thrombolysis therapy within 4 weeks before randomization
Presence of any acute or chronic systemic infection
Major surgical procedures, or open biopsy within 4 weeks before randomization
Chronic concurrent therapy within 2 weeks before and during the initial treatment period (Day 1 to Day 7):
Known multi-drug resistant gram-negative bacteria
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the study results or render the patient at high risk for treatment complications
Women of childbearing potential
Primary purpose
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Interventional model
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6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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