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

NCT ID: NCT00559117

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2015-06-30

Brief Summary

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

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

Conditions

Advanced and/or Metastatic Solid Organ Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort

Group Type: EXPERIMENTAL

VB-111

Intervention Type: DRUG

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

Interventions

VB-111

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vascular Biogenics Ltd. operating as VBL Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Triozzi, Dr.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Andrew Brenner, MD

Role: PRINCIPAL_INVESTIGATOR

UTHSC- CTRC and Institute for Drug Development

Locations

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

Countries

United States

Other Identifiers

GT-111001 (VB-111)

Identifier Type: -

Identifier Source: org_study_id