A Phase I Study to Assess the Safety and Distribution of VB-111 in Patients With Advanced Metastatic Cancer

Study Overview
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Brief Summary
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Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer

Detailed Description
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Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.

Official Title
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A Phase I, Open-Label, Dose Ranging Study to Assess the Safety and Distribution of Single or Multiple Doses of VB-111 in Patients With Advanced Metastatic Cancer

Conditions
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Advanced and/or Metastatic Solid Organ Cancer

Intervention / Treatment
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* Drug: VB-111


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years of age Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For Cohort 8, malignancy will include only NET or RCC. Karnofsky performance status of ≥70% Patients with an adequate hematological profile Patients with an adequate renal function Males and Females of childbearing potential must utilize a standard contraception method Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Pregnant or breastfeeding patients Patients, who suffered from an acute cardiac event within the last 12 months Patients with active vascular disease, either myocardial or peripheral Patients with proliferative and/or vascular retinopathy Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) Patients with known CNS metastatic disease Patients testing positive to one of the following viruses: HIV, HBV or HCV Patients receiving chemotherapy or radiotherapy within the last 4 weeks before enrolment Patients that have undergone major surgery within the last 4 weeks before enrolment Patients may not have received anti-angiogenic therapy within the previous 8 weeks before enrolment. Patients may not have received any other investigational agent within 4 weeks before enrolment. Patients with an ongoing requirement for an immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before enrolment Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort<br> | Drug: VB-111<br>* A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) |  | 2 months |