Title

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

    Phase 1
  • Lead Sponsor

    VBL
  • Study Type

    Interventional
  • Status

    Unknown status
  • Intervention/Treatment

    vb-111 ...
  • Study Participants

    48
Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer
Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.
Study Started
Nov 30
2007
Primary Completion
Jun 30
2015
Anticipated
Study Completion
Jun 30
2015
Anticipated
Last Update
Mar 27
2015
Estimate

Drug VB-111

A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute

Cohort Experimental

Criteria

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
No Results Posted