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

Status unconfirmed · Phase 1

Conditions studied: Advanced and/or Metastatic Solid Organ Cancer

In brief

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

Key facts

Study ID

NCT00559117

Run by

Vascular Biogenics Ltd. operating as VBL Therapeutics

People needed

48

Starts

2007-11-01

Expected to finish

2015-06-01

Last updated by the study team

2015-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Dana Farber/Brigham and Women's Cancer Center — Boston, Massachusetts, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UTHSC- CTRC and Institute for Drug Development — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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